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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name suture, nonabsorbable, synthetic, polyethylene
510(k) Number K121861
Model 72201490, 72201491, 72201492, 72201493, 72201494, 72201495, 72202467, 72202468, 72202469
Device Name SMITH & NEPHEW ULTRA FAST-FIX MENISCAL REPAIR SYSTEM, SMITH & NEPHEW ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEM, SMITH & N
Original Applicant
SMITH & NEPHEW, INC.
150 minuteman rd.
andover,  MA  01810
Original Contact karin desjardins
Regulation Number878.5000
Classification Product Code
GAT  
Date Received06/26/2012
Decision Date 10/18/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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