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Platelet And Plasma Separator For Bone Graft Handling

Celling Biosciences, Inc.

The following data is part of a premarket notification filed by Celling Biosciences, 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 IDBK150221
510k NumberBK150221
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
ClassificationPlatelet And Plasma Separator For Bone Graft Handling
Applicant Celling Biosciences, Inc. 93 Red River St. Austin,  TX  78701
Product CodeORG  
CFR Regulation Number864.9245 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Special
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-02-03
Decision Date2015-06-09

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817771027613 BK150221 0
00817771027569 BK150221 0
00817771027552 BK150221 0
00817771027545 BK150221 0
00817771027538 BK150221 0
00817771027507 BK150221 0
00817771027491 BK150221 0
00817771029983 BK150221 0
00817771028887 BK150221 0

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