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Syringe, Piston

SPINESMITH PARTNERS LP

The following data is part of a premarket notification filed by Spinesmith Partners Lp 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 IDBK090047
510k NumberBK090047
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 SPINESMITH PARTNERS LP 93 Red River Austin,  TX  78701
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-09-08
Decision Date2010-02-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817771027392 BK090047 0
00817771027385 BK090047 0
00817771027378 BK090047 0
00817771027361 BK090047 0
00817771027354 BK090047 0
00817771027323 BK090047 0
00817771027316 BK090047 0

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