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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 K142208
Device Name Monopolar Laparascopic Accessories
Applicant
Unimicro Medical Systems (Shenzhen) Co., Ltd.
2/F,Bldg31,3rd Industrial Area,Mashantou
Guangming St.,Guangming New District
Shenzhen,  CN 518106
Applicant Contact Weizhong Chen
Correspondent
Shenzen Hlongmed Biotech Co., Ltd.
R15-08, E. Bldg., Yihai Plz., Chuangye Rd., Nanshan D
Shenzhen,  CN 518054
Correspondent Contact Long Yang
Regulation Number878.4400
Classification Product Code
GEI  
Date Received08/11/2014
Decision Date 04/13/2015
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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