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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 K132771
Device Name KINGSTON ENDOSCOPIC SURGICAL INSTRUMENTS
Applicant
Qingdao Kingston Medical Devices, Ltd.
#5 Seoul Rd.
Free Trade Zone
Qingdao, Shandong,  CN 266555
Applicant Contact WU HANHUA
Correspondent
Qingdao Kingston Medical Devices, Ltd.
#5 Seoul Rd.
Free Trade Zone
Qingdao, Shandong,  CN 266555
Correspondent Contact WU HANHUA
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/05/2013
Decision Date 10/28/2014
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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