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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 K952792
Device Name PADLESS ELECTROSURGICAL PENCIL
Applicant
Lca, Inc.
7840 Montgomery Rd.
Cincinnati,  OH  45236
Applicant Contact GARY LONG
Correspondent
Lca, Inc.
7840 Montgomery Rd.
Cincinnati,  OH  45236
Correspondent Contact GARY LONG
Regulation Number878.4400
Classification Product Code
GEI  
Date Received06/19/1995
Decision Date 08/28/1995
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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