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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Cautery, Thermal, Ac-Powered
510(k) Number K943031
Device Name BIPOLAR ELECTROSURGICAL PENCIL
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 Number886.4115
Classification Product Code
HQO  
Date Received06/27/1994
Decision Date 09/23/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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