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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 K143103
Device Name PROPENCIL Smoke Pencil
Applicant
Bio Protech, Inc.
Donghwa Medical Instrument Complex, 151-3,
Donghwagongdan-Ro, Munmak-Eup
Wonju-Si,  KR 220-801
Applicant Contact Terry Kim
Correspondent
Bio Protech USA, Inc.
2601 Walnut Ave.
Tustin,  CA  92780
Correspondent Contact Kevin Han
Regulation Number878.4400
Classification Product Code
GEI  
Date Received10/29/2014
Decision Date 07/16/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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