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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 K151229
Device Name ABC D-FLEX PROBE
Applicant
Conmed Corporation
525 French Rd.
Utica,  NY  11502
Applicant Contact SANDY LECLAIR
Correspondent
Conmed Corporation
525 French Rd.
Utica,  NY  11502
Correspondent Contact Lisa B Anderson
Regulation Number878.4400
Classification Product Code
GEI  
Date Received05/07/2015
Decision Date 06/02/2016
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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