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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 IDBK130049
510k NumberBK130049
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 ProductYes
Date Received2013-09-18
Decision Date2014-01-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08435389811275 BK130049 000
08435389811213 BK130049 000
08435389811206 BK130049 000
08435389811138 BK130049 000

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