D I R R A S R L

FDA Filings

This page includes the latest FDA filings for D I R R A S R L. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
PMN K041080 D.I.R.R.A. S.R.L.	SURGICAL DRAPE KIT - D.I.R.R.A. SRL	2004-11-30

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• DEPUY, INC.p.o. Box 988700 Orthopaedic Drivewarsaw, IN 46581-0988 PMA NumberP830055 Supplement NumberS303 Date Received01/11/2023 Decision Date02/01/2023 Product Code NJL  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DEPUY, INC.p.o. Box 988700 Orthopaedic Drivewarsaw, IN 46581-0988 PMA NumberP830055 Supplement NumberS302 Date Received01/05/2023 Decision Date01/30/2023 Product Code NJL  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DEXCOM, INC.6340 Sequence Drsan Diego, CA 92121 PMA NumberP120005 Supplement NumberS090 Date Received10/14/2022 Decision Date01/12/2023 Product Code MDS  Advisory Committee Clinical Chemistry Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
• DiaSorin Inc1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP190017 Supplement NumberS008 Date Received09/21/2022 Decision Date12/21/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180039 Supplement NumberS013 Date Received11/10/2022 Decision Date12/08/2022 Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180045 Supplement NumberS011 Date Received11/10/2022 Decision Date12/08/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180038 Supplement NumberS014 Date Received11/10/2022 Decision Date12/08/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin, Inc.1951 Northwestern Avenuestillwater, MN 55082-0285 PMA NumberP180047 Supplement NumberS022 Date Received11/10/2022 Decision Date12/08/2022 Product Code NCD  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180048 Supplement NumberS011 Date Received11/10/2022 Decision Date12/08/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180049 Supplement NumberS011 Date Received11/10/2022 Decision Date12/08/2022 Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DEPUY ORTHOPAEDICS, INC.700 Orthopaedic Drivewarsaw, IN 46582 PMA NumberP070026 Supplement NumberS103 Date Received11/28/2022 Decision Date12/08/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin Inc1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP190017 Supplement NumberS010 Date Received11/10/2022 Decision Date12/08/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DEPUY, INC.p.o. Box 988700 Orthopaedic Drivewarsaw, IN 46581-0988 PMA NumberP830055 Supplement NumberS300 Date Received10/27/2022 Decision Date11/14/2022 Product Code NJL  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DEPUY, INC.p.o. Box 988700 Orthopaedic Drivewarsaw, IN 46581-0988 PMA NumberP830055 Supplement NumberS299 Date Received09/30/2022 Decision Date10/07/2022 Product Code NJL  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DEPUY, INC.p.o. Box 988700 Orthopaedic Drivewarsaw, IN 46581-0988 PMA NumberP830055 Supplement NumberS296 Date Received09/07/2022 Decision Date10/04/2022 Product Code NJL  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DEPUY, INC.p.o. Box 988700 Orthopaedic Drivewarsaw, IN 46581-0988 PMA NumberP830055 Supplement NumberS297 Date Received09/23/2022 Decision Date10/04/2022 Product Code NJL  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DEPUY ORTHOPAEDICS, INC.700 Orthopaedic Drivewarsaw, IN 46582 PMA NumberP070026 Supplement NumberS102 Date Received09/07/2022 Decision Date10/04/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DJO Global9800 Metric Boulevardaustin, TX 78758 PMA NumberP050050 Supplement NumberS025 Date Received09/02/2022 Decision Date09/29/2022 Product Code NTG  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DEPUY, INC.p.o. Box 988700 Orthopaedic Drivewarsaw, IN 46581-0988 PMA NumberP830055 Supplement NumberS295 Date Received08/12/2022 Decision Date09/01/2022 Product Code NJL  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DEPUY ORTHOPAEDICS, INC.700 Orthopaedic Drivewarsaw, IN 46582 PMA NumberP070026 Supplement NumberS101 Date Received07/28/2022 Decision Date08/26/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DEPUY, INC.p.o. Box 988700 Orthopaedic Drivewarsaw, IN 46581-0988 PMA NumberP830055 Supplement NumberS294 Date Received08/01/2022 Decision Date08/15/2022 Product Code NJL  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin, Inc.1951 Northwestern Avenuestillwater, MN 55082-0285 PMA NumberP180047 Supplement NumberS018 Date Received07/15/2022 Decision Date08/11/2022 Product Code NCD  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DEPUY, INC.p.o. Box 988700 Orthopaedic Drivewarsaw, IN 46581-0988 PMA NumberP830055 Supplement NumberS293 Date Received07/15/2022 Decision Date08/11/2022 Product Code NJL  Advisory Committee Orthopedic Supplement Typespecial (immediate Track) Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DEPUY ORTHOPAEDICS, INC.700 Orthopaedic Drivewarsaw, IN 46582 PMA NumberP070026 Supplement NumberS100 Date Received07/01/2022 Decision Date07/12/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin, Inc.1951 Northwestern Avenuestillwater, MN 55082-0285 PMA NumberP180047 Supplement NumberS017 Date Received04/13/2022 Decision Date07/08/2022 Product Code NCD  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• DEPUY, INC.p.o. Box 988700 Orthopaedic Drivewarsaw, IN 46581-0988 PMA NumberP830055 Supplement NumberS292 Date Received06/27/2022 Decision Date07/06/2022 Product Code NJL  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DEPUY, INC.p.o. Box 988700 Orthopaedic Drivewarsaw, IN 46581-0988 PMA NumberP830055 Supplement NumberS289 Date Received06/01/2022 Decision Date06/29/2022 Product Code NJL  Advisory Committee Orthopedic Supplement Typespecial (immediate Track) Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180039 Supplement NumberS011 Date Received04/05/2022 Decision Date06/23/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180048 Supplement NumberS009 Date Received04/05/2022 Decision Date06/23/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180038 Supplement NumberS012 Date Received04/05/2022 Decision Date06/23/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin Inc1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP190017 Supplement NumberS006 Date Received04/05/2022 Decision Date06/23/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin, Inc.1951 Northwestern Avenuestillwater, MN 55082-0285 PMA NumberP180047 Supplement NumberS016 Date Received04/05/2022 Decision Date06/23/2022 Product Code NCD  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180049 Supplement NumberS009 Date Received04/05/2022 Decision Date06/23/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180045 Supplement NumberS009 Date Received04/05/2022 Decision Date06/23/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DEPUY ORTHOPAEDICS, INC.700 Orthopaedic Drivewarsaw, IN 46582 PMA NumberP070026 Supplement NumberS098 Date Received05/09/2022 Decision Date06/07/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin, Inc.1951 Northwestern Avenuestillwater, MN 55082-0285 PMA NumberP180047 Supplement NumberS015 Date Received04/05/2022 Decision Date05/06/2022 Product Code NCD  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180048 Supplement NumberS008 Date Received04/05/2022 Decision Date05/06/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin Inc1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP190017 Supplement NumberS005 Date Received04/05/2022 Decision Date05/06/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180045 Supplement NumberS008 Date Received04/05/2022 Decision Date05/06/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180039 Supplement NumberS010 Date Received04/05/2022 Decision Date05/06/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180049 Supplement NumberS008 Date Received04/05/2022 Decision Date05/06/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180038 Supplement NumberS011 Date Received04/05/2022 Decision Date05/06/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180045 Supplement NumberS007 Date Received02/04/2022 Decision Date05/05/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• DEPUY ORTHOPAEDICS, INC.700 Orthopaedic Drivewarsaw, IN 46582 PMA NumberP070026 Supplement NumberS097 Date Received04/07/2022 Decision Date05/05/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Typespecial (immediate Track) Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin, Inc.1951 Northwestern Avenuestillwater, MN 55082-0285 PMA NumberP180047 Supplement NumberS014 Date Received02/04/2022 Decision Date05/05/2022 Product Code NCD  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• DiaSorin Inc1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP190017 Supplement NumberS004 Date Received02/04/2022 Decision Date05/05/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180049 Supplement NumberS007 Date Received02/04/2022 Decision Date05/05/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180038 Supplement NumberS010 Date Received02/04/2022 Decision Date05/05/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180048 Supplement NumberS007 Date Received02/04/2022 Decision Date05/05/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180039 Supplement NumberS009 Date Received02/04/2022 Decision Date05/05/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• DEPUY, INC.p.o. Box 988700 Orthopaedic Drivewarsaw, IN 46581-0988 PMA NumberP830055 Supplement NumberS288 Date Received04/19/2022 Decision Date04/27/2022 Product Code NJL  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DEPUY ORTHOPAEDICS, INC.700 Orthopaedic Drivewarsaw, IN 46582 PMA NumberP070026 Supplement NumberS096 Date Received04/06/2022 Decision Date04/14/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Dilon Medical Technologies, Ltd.20 Alon Hatavor Streetp.o. Box 3131business Park-south 3088900  PMA NumberP110014 Supplement NumberS012 Date Received10/14/2021 Decision Date04/06/2022 Product Code OEE  Advisory Committee General & Plastic Surgery Clinical TrialsNCT02406599 Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Pas Expedited Review Granted? No
• DEPUY, INC.p.o. Box 988700 Orthopaedic Drivewarsaw, IN 46581-0988 PMA NumberP830055 Supplement NumberS285 Date Received03/02/2022 Decision Date03/29/2022 Product Code NJL  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DEPUY, INC.p.o. Box 988700 Orthopaedic Drivewarsaw, IN 46581-0988 PMA NumberP830055 Supplement NumberS284 Date Received02/22/2022 Decision Date03/24/2022 Product Code NJL  Advisory Committee Orthopedic Supplement Typespecial (immediate Track) Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DEPUY ORTHOPAEDICS, INC.700 Orthopaedic Drivewarsaw, IN 46582 PMA NumberP070026 Supplement NumberS094 Date Received02/22/2022 Decision Date03/22/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Typespecial (immediate Track) Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Datex-Ohmeda, Inc., A General Electric Companyp.o. Box 7550madison, WI 53707-7550 PMA NumberP210018 Date Received05/03/2021 Decision Date03/17/2022 Product Code QSF  Advisory Committee Anesthesiology Clinical TrialsNCT02972892 Expedited Review Granted? No
• DJO Global9800 Metric Boulevardaustin, TX 78758 PMA NumberP050050 Supplement NumberS022 Date Received02/01/2022 Decision Date03/11/2022 Product Code NTG  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DEPUY ORTHOPAEDICS, INC.700 Orthopaedic Drivewarsaw, IN 46582 PMA NumberP070026 Supplement NumberS093 Date Received02/14/2022 Decision Date03/10/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DEPUY, INC.p.o. Box 988700 Orthopaedic Drivewarsaw, IN 46581-0988 PMA NumberP830055 Supplement NumberS282 Date Received02/11/2022 Decision Date03/08/2022 Product Code NJL  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DEPUY ORTHOPAEDICS, INC.700 Orthopaedic Drivewarsaw, IN 46582 PMA NumberP070026 Supplement NumberS091 Date Received02/11/2022 Decision Date02/22/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DEPUY, A JOHNSON & JOHNSON CO.p.o. Box 988700 Orthopaedic Drivewarsaw, IN 46581-0988 PMA NumberP960054 Supplement NumberS003 Date Received08/10/1999 Decision Date12/22/1999 Reclassified Date 05/30/2002 Product Code KWZ  Advisory Committee Orthopedic Supplement Typenormal 180 Day Track Supplement Reason Location Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DEPUY, A JOHNSON & JOHNSON CO.p.o. Box 988700 Orthopaedic Drivewarsaw, IN 46581-0988 PMA NumberP960054 Supplement NumberS002 Date Received07/30/1999 Decision Date12/07/1999 Reclassified Date 05/30/2002 Product Code KWZ  Advisory Committee Orthopedic Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• DEPUY, A JOHNSON & JOHNSON CO.p.o. Box 988700 Orthopaedic Drivewarsaw, IN 46581-0988 PMA NumberP960054 Supplement NumberS004 Date Received10/06/1999 Decision Date11/10/1999 Reclassified Date 05/30/2002 Product Code KWZ  Advisory Committee Orthopedic Supplement Typenormal 180 Day Track Supplement Reason Location Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Fo
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