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Platelet And Plasma Separator For Bone Graft Handling

B.T.I Biotechnology Institute, S.L.

The following data is part of a premarket notification filed by B.t.i Biotechnology Institute, S.l. 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 IDBK150294
510k NumberBK150294
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 B.T.I Biotechnology Institute, S.L. leonardo Davinci 14 parque Tecnologico De Alava Minano,  Alava,  01510,  SP
Product CodeORG  
CFR Regulation Number864.9245 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-07-13
Decision Date2015-12-09

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08435389815587 BK150294 000

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