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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 K210909
Device Name easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use
Applicant
Ezisurg Medical Co., Ltd.
Rm. 103, Bldg. 2, #1690 Cailun Rd., China (Shanghai) Pilot
Shanghai,  CN 201203
Applicant Contact Jingtian Ren
Correspondent
Mid-Linking Consulting Co., Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number878.4750
Classification Product Code
GDW  
Subsequent Product Code
GAG  
Date Received03/29/2021
Decision Date 06/24/2021
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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