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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 K892502
Device Name ELECTROSURGICAL PENCIL
Applicant
Yuntek International, Inc.
28306 Industrial Blvd., Suite
E.
Hayward,  CA  94545
Applicant Contact DAVID CHOU
Correspondent
Yuntek International, Inc.
28306 Industrial Blvd., Suite
E.
Hayward,  CA  94545
Correspondent Contact DAVID CHOU
Regulation Number878.4400
Classification Product Code
GEI  
Date Received04/11/1989
Decision Date 05/15/1989
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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