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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 K220186
Device Name Zone Specific AIM
Applicant
Conmed Corporation
525 French Rd.
Utica,  NY  13502
Applicant Contact Orjada Dervishleri
Correspondent
Conmed Corporation
11311 Concept Blvd.
Largo,  FL  33773
Correspondent Contact Orjada Dervishleri
Regulation Number878.5000
Classification Product Code
GAT  
Subsequent Product Code
MBI  
Date Received01/24/2022
Decision Date 05/13/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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