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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 K181657
Device Name easyLCTM Linear Cutter Staplers and Loading Units fot Single Use; easyCSTM Circular Stapler for Single Use
Ezisurg Medical Co., Ltd.
Rm. 103, Bldg.2, No.1690 Cailun Road
China (Shanghai) Pilot Free Trade Zone
Shanghai,  CN 201203
Applicant Contact Liang Xia
Mid-Link Consulting Co., Ltd
P.O.BOX 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number878.4750
Classification Product Code
Date Received06/22/2018
Decision Date 02/01/2019
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