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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 K972901
Device Name AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORD
Applicant
American Biosurgical, Inc.
6665-B Corners Industrial Ct.
Norcross,  GA  30092
Applicant Contact MICHAEL SOCOLOFF
Correspondent
American Biosurgical, Inc.
6665-B Corners Industrial Ct.
Norcross,  GA  30092
Correspondent Contact MICHAEL SOCOLOFF
Regulation Number878.4400
Classification Product Code
GEI  
Date Received08/06/1997
Decision Date 09/19/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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