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

Cord Blood Processing System And Storage Container

Biosafe SA

The following data is part of a premarket notification filed by Biosafe Sa 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 IDBK090037
510k NumberBK090037
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
ClassificationCord Blood Processing System And Storage Container
Applicant Biosafe SA route Du Petit-eysins Eysins,  Vaud,  1262,  SZ
Product CodeOAO  
CFR Regulation Number864.9900 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-08-03
Decision Date2010-03-22

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07640125650570 BK090037 0
7640125650396 BK090037 0
07640125650419 BK090037 0
07640125650495 BK090037 0
07640125650501 BK090037 0
07640125650518 BK090037 0
07640125650549 BK090037 0
07640125650556 BK090037 0
07640125650563 BK090037 0
07640125650372 BK090037 0

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.