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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 K132136
Device Name SINGLE USE GROUNDING PAD
Applicant
Lccs Products Limited
7th Floor, Jinggui Business Bldg, # 982 Congyun Rd.,
Baiyun District
Guangzhou, Guangdong,  CN 510420
Correspondent
Lccs Products Limited
7th Floor, Jinggui Business Bldg, # 982 Congyun Rd.,
Baiyun District
Guangzhou, Guangdong,  CN 510420
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
JOS  
Date Received07/11/2013
Decision Date 09/06/2013
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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