B B Co Co L T D

FDA Filings

This page includes the latest FDA filings for B B Co Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3004105180
• FEI Number: 3004105180
• Name: Mark Seidel
• Owner & Operator: B&B COMPANY CO., LTD.
• Contact Address: 62-9, Techno 1-ro ; Yuseong-gu KR-30 Daejeon Gwangyeogsi 34014 KR
• Official Correspondent:
  • Sangri Park
  • 82-42-5833246-x
• US Agent:
  • Mark Seidel
  • Cancer Diagnostics, INC
  • 877 8465393
  • 877 8171716
  • mseidel@cancerdiagnostics.com
• Importing Logistics Registration:
  • Importer: Cancer Diagnostics, Inc
  • Address: Box 1205 ; Birmingham, MI 48012 UNITED STATES
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Durham, NC, 4300 Emperor Blvd. #400 Durham, North Carolina, 27703, USA; Durham, NC 27703 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 08809157488547 B&B Company Co.,Ltd.	C60100	2023-07-25
GUDID 08809157488530 B&B Company Co.,Ltd.	C60100	2023-07-25
GUDID 08809157488523 B&B Company Co.,Ltd.	C60100	2023-07-25
GUDID 08809157488516 B&B Company Co.,Ltd.	C60100	2023-07-25
GUDID 08809157488448 B&B Company Co.,Ltd.	C29000	2023-07-25
GUDID 08809157488431 B&B Company Co.,Ltd.	C29000	2023-07-25
GUDID 08809157488424 B&B Company Co.,Ltd.	C29000	2023-07-25
GUDID 08809157488417 B&B Company Co.,Ltd.	C29000	2023-07-25
GUDID 08809157488349 B&B Company Co.,Ltd.	C27632	2023-07-25
GUDID 08809157488332 B&B Company Co.,Ltd.	C27632	2023-07-25
GUDID 08809157488325 B&B Company Co.,Ltd.	C27632	2023-07-25
GUDID 08809157488318 B&B Company Co.,Ltd.	C27632	2023-07-25
GUDID 08809157488240 B&B Company Co.,Ltd.	C27024	2023-07-25
GUDID 08809157488233 B&B Company Co.,Ltd.	C27024	2023-07-25
GUDID 08809157488226 B&B Company Co.,Ltd.	C27024	2023-07-25
GUDID 08809157488219 B&B Company Co.,Ltd.	C27024	2023-07-25
GUDID 08809157488141 B&B Company Co.,Ltd.	C21150	2023-07-25
GUDID 08809157488134 B&B Company Co.,Ltd.	C21150	2023-07-25
GUDID 08809157488127 B&B Company Co.,Ltd.	C21150	2023-07-25
GUDID 08809157488110 B&B Company Co.,Ltd.	C21150	2023-07-25
GUDID 08809157488042 B&B Company Co.,Ltd.	C20310	2023-07-25
GUDID 08809157488035 B&B Company Co.,Ltd.	C20310	2023-07-25
GUDID 08809157488028 B&B Company Co.,Ltd.	C20310	2023-07-25
GUDID 08809157488011 B&B Company Co.,Ltd.	C20310	2023-07-25
GUDID 08809157486338 B&B Company Co.,Ltd.	e-sarang HAPPINESS SET 3	2023-07-25
GUDID 08809157486321 B&B Company Co.,Ltd.	e-sarang HAPPINESS SET 3	2023-07-25
GUDID 08809157486215 B&B Company Co.,Ltd.	e-sarang WHITECLEAR	2023-07-25
GUDID 08809157486109 B&B Company Co.,Ltd.	e-sarang TRAVEL KIT	2023-07-25
GUDID 08809157484129 B&B Company Co.,Ltd.	e-sarang DENTAL FLOSS 630D	2023-07-25
GUDID 08809157484112 B&B Company Co.,Ltd.	e-sarang	2023-07-25
GUDID 08809157484020 B&B Company Co.,Ltd.	e-sarang TONGUE CLEANER YELLOW	2023-07-25
GUDID 08809157484013 B&B Company Co.,Ltd.	e-sarang TONGUE CLEANER VIOLET	2023-07-25
GUDID 08809157482750 B&B Company Co.,Ltd.	e-sarang REFILLABLE INTERDENTAL BRUSH	2023-07-25
GUDID 08809157482545 B&B Company Co.,Ltd.	e-sarang L TYPE INTERDENTAL BRUSH XL 5P	2023-07-25
GUDID 08809157482538 B&B Company Co.,Ltd.	e-sarang L TYPE INTERDENTAL BRUSH L 5P	2023-07-25
GUDID 08809157482521 B&B Company Co.,Ltd.	e-sarang L TYPE INTERDENTAL BRUSH M 5P	2023-07-25
GUDID 08809157482514 B&B Company Co.,Ltd.	e-sarang	2023-07-25
GUDID 08809157481548 B&B Company Co.,Ltd.	e-sarang I TYPE INTERDENTAL BRUSH XL 5P	2023-07-25
GUDID 08809157481531 B&B Company Co.,Ltd.	e-sarang	2023-07-25
GUDID 08809157481524 B&B Company Co.,Ltd.	e-sarang I TYPE INTERDENTAL BRUSH M 5P	2023-07-25
GUDID 08809157481517 B&B Company Co.,Ltd.	e-sarang	2023-07-25
GUDID 08809157481401 B&B Company Co.,Ltd.	e-sarang	2023-07-25
GUDID 08809157480251 B&B Company Co.,Ltd.	e-sarang	2023-07-25
PMN K902591 | HHT Mark Seidel [B&B COMPANY CO., LTD.]	CDI	2014-05-07
PMN K902589 | HHT Mark Seidel [B&B COMPANY CO., LTD.]	CDI	2014-05-07
MNL Mark Seidel [B&B COMPANY CO., LTD.]	B&B BRUSH	2008-11-18
EFW Mark Seidel [B&B COMPANY CO., LTD.]	e-sarang	2008-01-24
EFW Mark Seidel [B&B COMPANY CO., LTD.]	Interdental Brush	2008-01-24

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• BECTON, DICKINSON AND COMPANY7 Loveton Circlesparks, MD 21152 PMA NumberP160037 Supplement NumberS011 Date Received10/21/2022 Decision Date11/19/2022 Product Code MAQ  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.one Scimed Placemaple Grove, MN 55311-1566 PMA NumberP950020 Supplement NumberS131 Date Received11/15/2022 Decision Date11/17/2022 Product Code NWX  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP070008 Supplement NumberS141 Date Received10/18/2022 Decision Date11/16/2022 Product Code NKE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.one Scimed Placemaple Grove, MN 55311-1566 PMA NumberP110010 Supplement NumberS205 Date Received10/17/2022 Decision Date11/15/2022 Product Code NIQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.one Scimed Placemaple Grove, MN 55311-1566 PMA NumberP060006 Supplement NumberS104 Date Received10/17/2022 Decision Date11/15/2022 Product Code NIN  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.one Scimed Placemaple Grove, MN 55311-1566 PMA NumberP130030 Supplement NumberS074 Date Received10/17/2022 Decision Date11/15/2022 Product Code MAF  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.150 Baytech Drivesan Jose, CA 95134 PMA NumberP150005 Supplement NumberS073 Date Received10/17/2022 Decision Date11/15/2022 Product Code OAD  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.150 Baytech Drivesan Jose, CA 95134 PMA NumberP980003 Supplement NumberS094 Date Received10/17/2022 Decision Date11/15/2022 Product Code LPB  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corporationthree Scimed Placemaple Grove, MN 55311-1566 PMA NumberP190019 Supplement NumberS016 Date Received10/17/2022 Decision Date11/15/2022 Product Code ONU  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.two Scimed Placemaple Grove, MN 55311-1566 PMA NumberP900056 Supplement NumberS203 Date Received10/17/2022 Decision Date11/15/2022 Product Code MCX  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BOSTON SCIENTIFIC150 Baytech Drivesan Jose, CA 95134 PMA NumberP020025 Supplement NumberS137 Date Received10/17/2022 Decision Date11/15/2022 Product Code OAD  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.150 Baytech Drivesan Jose, CA 95134 PMA NumberP920047 Supplement NumberS129 Date Received10/17/2022 Decision Date11/15/2022 Product Code LPB  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.100 Boston Scientific Waymarlborough, MA 01752 PMA NumberN970012 Supplement NumberS194 Date Received11/01/2022 Decision Date11/14/2022 Product Code JCW  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.100 Boston Scientific Waymarlborough, MA 01752 PMA NumberP000053 Supplement NumberS128 Date Received11/01/2022 Decision Date11/14/2022 Product Code EZY  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corporationthree Scimed Placemaple Grove, MN 55311-1566 PMA NumberP190019 Supplement NumberS015 Date Received10/06/2022 Decision Date11/10/2022 Product Code ONU  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BAXTER INTERNATIONAL, INC.1 Baxter Pkwy.deerfield, IL 60015-4633 PMA NumberP830063 Supplement NumberS024 Date Received10/18/2022 Decision Date11/08/2022 Product Code MDP  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.one Scimed Placemaple Grove, MN 55311-1566 PMA NumberP130013 Supplement NumberS055 Date Received10/18/2022 Decision Date11/07/2022 Product Code NGV  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.one Scimed Placemaple Grove, MN 55311-1566 PMA NumberP950020 Supplement NumberS129 Date Received10/25/2022 Decision Date11/07/2022 Product Code NWX  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.ballybrit Industrial Estate, Ballybritgalway H91 Y PMA NumberP110035 Supplement NumberS068 Date Received10/18/2022 Decision Date11/07/2022 Product Code NIO  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BOSTON SCIENTIFIC CORPORATIONone Scimed Placemaple Grove, MN 55311-1566 PMA NumberP140028 Supplement NumberS075 Date Received10/18/2022 Decision Date11/07/2022 Product Code NIP  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.one Scimed Placemaple Grove, MN 55311 PMA NumberP180011 Supplement NumberS051 Date Received10/18/2022 Decision Date11/07/2022 Product Code NIU  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.4100 Hamline Ave Northst. Paul, MN 55112 PMA NumberP010012 Supplement NumberS564 Date Received11/01/2022 Decision Date11/02/2022 Product Code NIK  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BOSTON SCIENTIFIC4100 Hamline Avenue Northst. Paul, MN 55112 PMA NumberP910073 Supplement NumberS170 Date Received11/01/2022 Decision Date11/02/2022 Product Code LWS  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BOSTON SCIENTIFIC4100 Hamline Avenue Northst. Paul, MN 55112 PMA NumberP930035 Supplement NumberS033 Date Received11/01/2022 Decision Date11/02/2022 Product Code LWS  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BOSTONSCIENTIFIC4100 Hamline Avenue Northst Paul, MN 55112 PMA NumberP150012 Supplement NumberS135 Date Received11/01/2022 Decision Date11/02/2022 Product Codes LWP NVN  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BOSTON SCIENTIFIC4100 Hamline Avenue Northst. Paul, MN 55112 PMA NumberP910077 Supplement NumberS189 Date Received11/01/2022 Decision Date11/02/2022 Product Code LWS  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BOSTON SCIENTIFIC4100 Hamline Avenue Northst. Paul, MN 55112 PMA NumberP960006 Supplement NumberS055 Date Received11/01/2022 Decision Date11/02/2022 Product Code NVN  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BOSTON SCIENTIFIC4100 Hamline Avenue Northst. Paul, MN 55112 PMA NumberP830060 Supplement NumberS088 Date Received11/01/2022 Decision Date11/02/2022 Product Code LWS  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BOSTON SCIENTIFIC4100 Hamline Avenue Northst. Paul, MN 55112 PMA NumberP960004 Supplement NumberS101 Date Received11/01/2022 Decision Date11/02/2022 Product Code NVN  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.one Scimed Placemaple Grove, MN 55311-1566 PMA NumberP130013 Supplement NumberS054 Date Received09/29/2022 Decision Date10/28/2022 Product Code NGV  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
• BOSTONSCIENTIFIC4100 Hamline Avenue Northst Paul, MN 55112 PMA NumberP150012 Supplement NumberS133 Date Received10/05/2022 Decision Date10/28/2022 Product Codes LWP NVN  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.4100 Hamline Ave Northst. Paul, MN 55112 PMA NumberN970003 Supplement NumberS279 Date Received10/05/2022 Decision Date10/28/2022 Product Code LWP  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BOSTON SCIENTIFIC CORPORATION4100 Hamline Avenue Northst. Paul, MN 55112-5798 PMA NumberP110042 Supplement NumberS175 Date Received10/05/2022 Decision Date10/28/2022 Product Codes LWS NVY  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOMET MANUFACTURING CORP.56 East Bell Drivep.o. Box 587warsaw, IN 46581-0587 PMA NumberP010014 Supplement NumberS103 Date Received09/29/2022 Decision Date10/25/2022 Product Code NRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP980023 Supplement NumberS115 Date Received09/22/2022 Decision Date10/20/2022 Product Code LWS  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP070008 Supplement NumberS140 Date Received09/22/2022 Decision Date10/20/2022 Product Code NKE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092830168	Pusan,South Korea -> Seattle, Washington	1 PALLETS OF OTHER INSTRUMENTS AND APPLIANCES CYTOLOGY BRUSH DIRECT JF NO:KRSEL/53/448935	1 PKG
2020022449880	Pusan,South Korea -> Tacoma, Washington	OTHER INSTRUMENTS AND APPLIANCES CYTOLOGY BRUSH . . .	2 PCS
2020022450478	Prince Rupert, BC ,Canada -> Tacoma, Washington	2 PALLETS OF OTHER INSTRUMENTS AND APPLIANCES CYTOLOGY BRUSH DIRECT JF NO:KRSEL/53/446232	2 PKG
2018070954963	Pusan,South Korea -> Seattle, Washington	CYTOLOGY BRUSH OTHER APPLIANCES USED IN MEDICAL . . .	2 PCS
2018040943149	Pusan,South Korea -> Seattle, Washington	CYTOLOGY BRUSH . . . .	2 PCS