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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 IDBK120057
510k NumberBK120057
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 3428 Avenue Marcil Montreal,  Quebec,  H4A 2Z3,  CA
Product CodeORG  
CFR Regulation Number864.9245 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-09-28
Decision Date2013-08-08

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08500331310011 BK120057 0

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