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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 K900533
Device Name DISPOSABLE BIPOLAR COAGULATING FORCEPS
Applicant
Kirwan Surgical Products, Inc.
83 E. Water St.
P.O. Box 545
Rockland,  MA  02370
Applicant Contact RICHARD M BEANE
Correspondent
Kirwan Surgical Products, Inc.
83 E. Water St.
P.O. Box 545
Rockland,  MA  02370
Correspondent Contact RICHARD M BEANE
Regulation Number878.4400
Classification Product Code
GEI  
Date Received01/23/1990
Decision Date 04/09/1990
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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