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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name staple, implantable
510(k) Number K162947
Device Name Disposable End-to-end Anastomosis Circular Stapler; Universal Endoscopic Linear Cutting Stapler and Single Use Loading Unit; Linear Cutting Stapler and Single Use Loading Unit; Disposal Hemorrhoidal Circular Stapler
Applicant
CHONGQING QMI SURGICAL CO., LTD
A ZONE 1ST FLOOR, YANGLIU ROAD NO.2 NORTH NEW ZONE
CHONGQING,  CN 401121
Applicant Contact KANG LI
Correspondent
MID-LINK CONSULTING CO., LTD
P.O. BOX 120-119
SHANGHAI,  CN 200120
Correspondent Contact DIANA HONG
Regulation Number878.4750
Classification Product Code
GDW  
Date Received10/21/2016
Decision Date 03/03/2017
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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