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Platelet And Plasma Separator For Bone Graft Handling

Cellmedix Holdings, LLC.

The following data is part of a premarket notification filed by Cellmedix Holdings, Llc. 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 IDBK130079
510k NumberBK130079
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 Cellmedix Holdings, LLC. 19 Park Drive Franklin,  NJ  07416
Product CodeORG  
CFR Regulation Number864.9245 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-12-12
Decision Date2014-07-31

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00861122000312 BK130079 0
10861122000302 BK130079 0

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