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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 K092634
Device Name OBS DISPOSABLE ELECTROSURGICAL PENCILS, MODELS: OBS-DB, OBS-DR, OBS-DF
Applicant
Jiangmen City Xinhui Baisheng Medical Equipment CO
Bldg. 1, #1, Huimin E.
Rd Huicheng Town, Xinhui Distr
Jiangmen City, Guangdong,  CN 529100
Applicant Contact CHEN XI
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact JAY KOGOMA
Regulation Number878.4400
Classification Product Code
GEI  
Date Received08/27/2009
Decision Date 12/01/2009
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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