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Platelet And Plasma Separator For Bone Graft Handling

RegenLab SA

The following data is part of a premarket notification filed by Regenlab 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 IDBK110061
510k NumberBK110061
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 RegenLab SA en Budron B2 ch-1052 Le Mont Sur Lausanne SZ
Product CodeORG  
CFR Regulation Number864.9245 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-10-27
Decision Date2012-05-08

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08500331310066 BK110061 0
08500331310042 BK110061 0

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