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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 K172960
Device Name easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use
Applicant
Ezisurg Medical Co., Ltd.
Rm. 103, Bldg. 2, #1690 Cailun Rd.,
China (Shanghai) Pilot Free Trade Zone
Shanghai,  CN 201203
Applicant Contact Sheng Tian
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 Received09/26/2017
Decision Date 12/21/2017
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
Predetermined Change
Control Plan Authorized		 No
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