FDA 510(k) Application Details - K073149

Device Classification Name Suture, Nonabsorbable, Synthetic, Polyethylene

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510(K) Number K073149
Device Name Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant ARTHREX, INC.
1370 CREEKSIDE BLVD.
NAPLES, FL 34108-1945 US
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Contact SALLY FOUST
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Regulation Number 878.5000

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Classification Product Code GAT
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Date Received 11/08/2007
Decision Date 02/11/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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