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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 K874779
Device Name BIPOLATOR 50
Applicant
Treace Medical, Inc.
Attorney At Law
22 N. Second St., Suite 400
Memphis,  TN  38102
Applicant Contact WILLIAM THOMAS
Correspondent
Treace Medical, Inc.
Attorney At Law
22 N. Second St., Suite 400
Memphis,  TN  38102
Correspondent Contact WILLIAM THOMAS
Regulation Number878.4400
Classification Product Code
GEI  
Date Received11/19/1987
Decision Date 01/29/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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