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Syringe, Piston

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 IDBK090048
510k NumberBK090048
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
ClassificationSyringe, Piston
Applicant RegenLab SA 3428 Avenue Marcil Montreal,  Quebec,  H4A 2Z3,  CA
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-08-28
Decision Date2010-05-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08500331310073 BK090048 0

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