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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K231732
Device Name CleanSeal Advanced Bipolar Vessel Sealer Maryland
Applicant
Conmed Corporation
525 French Rd.
Utica,  NY  13502
Applicant Contact Ali AbuSaleh
Correspondent
Conmed Corporation
525 French Rd.
Utica,  NY  13502
Correspondent Contact Ali AbuSaleh
Regulation Number878.4400
Classification Product Code
GEI  
Date Received06/13/2023
Decision Date 10/23/2023
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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