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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 K092732
Device Name PROPENCIL ESU PENCIL
Applicant
Bio Protech, Inc.
Taejang-2 Dong
Wonju-Si Gangwon-Do,  KR
Applicant Contact KEVIN HAN
Correspondent
Underwriters Laboratories, Inc.
333 Pfingsten Rd.
Northbrook,  IL  60062
Correspondent Contact NED DEVINE
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/04/2009
Decision Date 11/25/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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