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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clip, Implantable
510(k) Number K150936
Device Name SureClip
Applicant
Conmed Corporation
525 French Rd.
Utica,  NY  13502
Applicant Contact ANNA D'LIMA
Correspondent
Conmed Corporation
525 French Rd.
Utica,  NY  13502
Correspondent Contact Lisa Anderson
Regulation Number878.4300
Classification Product Code
FZP  
Date Received04/07/2015
Decision Date 10/23/2015
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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