FDA 510(k) Application Details - K220186

Device Classification Name Suture, Nonabsorbable, Synthetic, Polyethylene

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510(K) Number K220186
Device Name Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant CONMED Corporation
525 French Road
Utica, NY 13502 US
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Contact Orjada Dervishleri
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Regulation Number 878.5000

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Classification Product Code GAT
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Date Received 01/24/2022
Decision Date 05/13/2022
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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