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Bone Marrow Processing Device To Support Hematopoietic Reconstitution

Terumo BCT, Inc

The following data is part of a premarket notification filed by Terumo Bct, Inc with the FDA for 510(k) Premarket Notification // 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 Food Drugs Medical Devices .

Pre-market Notification Details

Device IDBK140191
510k NumberBK140191
Device Name:510(k) Premarket Notification // 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 Food Drugs Medical Devices
ClassificationBone Marrow Processing Device To Support Hematopoietic Reconstitution
Applicant Terumo BCT, Inc 10811 W. Collins Ave. Lakewood,  CO  80215 US
Product CodePKG  
CFR Regulation Number864.9245 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-11-10
Decision Date2015-03-09

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
35020583113009 BK140191 0
05020583113008 BK140191 0

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