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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 K183477
Device Name easyPPHTM Hemorrhoidal Stapler for Single Use
Applicant
Ezisurg Medical Co., Ltd.
Rm.103, Bldg.2, No.1690 Cailun Rd.
China(Shanghai) Pilot Free Trade Zone
Shanghai,  CN 201203
Applicant Contact Liang Xia
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  
Subsequent Product Code
GAG  
Date Received12/17/2018
Decision Date 02/11/2019
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
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