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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 K122374
Device Name ARTHREX SUTURE (UHMWPE)
Original Applicant
ARTHREX, INC.
1370 creekside blvd.
naples,  FL  34108 1945
Original Contact ivette galmez
Regulation Number878.5000
Classification Product Code
GAT  
Date Received08/06/2012
Decision Date 09/25/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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