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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 K844371
Device Name HAND CONTROLLED ELECTROSURGICAL PENCIL-REUSEABLE
Applicant
Consolidated Medical Equipment, Inc.
310 Broad St.
Utica,  NY  13501
Applicant Contact WILLIAM W ABRAHAM
Correspondent
Consolidated Medical Equipment, Inc.
310 Broad St.
Utica,  NY  13501
Correspondent Contact WILLIAM W ABRAHAM
Regulation Number878.4400
Classification Product Code
GEI  
Date Received11/13/1984
Decision Date 02/20/1985
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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