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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 K112899
Device Name ARTHREX BIO-SUTURE
Original Applicant
ARTHREX, INC.
1370 creekside blvd.
naples,  FL  34108 1945
Original Contact sally foust
Regulation Number878.5000
Classification Product Code
GAT  
Date Received10/03/2011
Decision Date 04/06/2012
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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