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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 K913514
Device Name ELECTROSURGICAL UNIT CABLE
Applicant
Kirwan Surgical Products, Inc.
83 E. Water St.
P.O. Box 545
Rockland,  MA  02370
Applicant Contact FRED TERRY
Correspondent
Kirwan Surgical Products, Inc.
83 E. Water St.
P.O. Box 545
Rockland,  MA  02370
Correspondent Contact FRED TERRY
Regulation Number878.4400
Classification Product Code
GEI  
Date Received08/07/1991
Decision Date 11/05/1991
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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