FDA 510(k) Application Details - K220880

Device Classification Name Suture, Nonabsorbable, Synthetic, Polyethylene

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510(K) Number K220880
Device Name Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant Arthrex Inc.
1370 Creekside Boulevard
Naples, FL 34108-1945 US
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Contact Stacy Valdez
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Regulation Number 878.5000

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Classification Product Code GAT
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Date Received 03/25/2022
Decision Date 10/27/2022
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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