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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 K944947
Device Name ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESS
Applicant
Boston Surgical Products, Inc.
203 Indian Pond Rd.
Kingston,  MA  02364
Applicant Contact LAWRENCE T KIRWAN
Correspondent
Boston Surgical Products, Inc.
203 Indian Pond Rd.
Kingston,  MA  02364
Correspondent Contact LAWRENCE T KIRWAN
Regulation Number878.4400
Classification Product Code
GEI  
Date Received10/07/1994
Decision Date 07/28/1995
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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