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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 K972311
Device Name MODEL 20 BIPOLAR COAGULATOR
Applicant
Boston Surgical Products, Inc.
17 Old Country Rd.
Oxford,  CT  06478
Applicant Contact CHARLES VASSALLO
Correspondent
Boston Surgical Products, Inc.
17 Old Country Rd.
Oxford,  CT  06478
Correspondent Contact CHARLES VASSALLO
Regulation Number878.4400
Classification Product Code
GEI  
Date Received06/20/1997
Decision Date 09/18/1997
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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