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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 K143129
Device Name easyEndo Linear Cutting Stapler and Loading Unit for Single Use(Stapler;Loading Unit)
Applicant
EziSurg Medical Co.,Ltd.
Room 312, Bldg 2, No.1690 Cailun Road
Zhangjiang High-Tech Park,Pudong
Shanghai,  CN 201203
Applicant Contact Johnny Yan
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 Received10/31/2014
Decision Date 01/29/2015
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
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