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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 K952161
Device Name BIPOLAR COAGULATION INSTRUMENT
Applicant
Johnson & Johnson Professionals, Inc.
Rte. 202 N.
Raritan,  NJ  08869
Applicant Contact JOHN D FERROS
Correspondent
Johnson & Johnson Professionals, Inc.
Rte. 202 N.
Raritan,  NJ  08869
Correspondent Contact JOHN D FERROS
Regulation Number878.4400
Classification Product Code
GEI  
Date Received05/08/1995
Decision Date 07/05/1995
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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