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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 K162707
Device Name Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload
Golden Stapler Surgical Co., Ltd.
Building 7A,Jiangsu Wujin Sci-Tech Pioneer Park,256
Mid Mingxin Road
Changzhou,  CN 213164
Applicant Contact Hao Chao
Mid-Link Consulting Co.,Ltd
P.O.BOX 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number878.4750
Classification Product Code
Date Received09/28/2016
Decision Date 07/14/2017
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