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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 K051956
Device Name DR. OPPEL ST-501
Applicant
Sometech Incorporated
2f, Byuksan Digital Valley Iii
212-13, Gurodong, Guro-Ku
Seoul,  KR 152-050
Applicant Contact YOUNG-SOO SEOL
Correspondent
Underwriters Laboratories, Inc.
2600 NW Lake Rd.
Camas,  WA  98607
Correspondent Contact MARC M MOUSER
Regulation Number878.4400
Classification Product Code
GEI  
Date Received07/19/2005
Decision Date 09/08/2005
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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