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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
No.5 Seoul Road
Free Trade Zone
QINGDAO, SHANDONG,  CN 266555
Applicant Contact WU HANHUA
Correspondent
QINGDAO KINGSTON MEDICAL DEVICES LTD
No.5 Seoul Road
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
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