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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 K161905
Device Name Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscopic Linear Cutter Stapler and Cartridge, Disposable Linear Cutter Stapler and Stapler Cartridge
Applicant
CHANGZHOU XIN NENG YUAN MEDICAL STAPLER CO.,LTD.
NO.51, SHUISHAN RD, ZHONGLOU ECONOMIC DEVELOPMENT ZONE
Changzhou,  CN 213023
Applicant Contact Boping Ma
Correspondent
MID-LINK CONSULTING CO.,LTD
P.O.BOX 120-119
Shanghai,  CN 100102
Correspondent Contact Diana Hong
Regulation Number878.4750
Classification Product Code
GDW  
Subsequent Product Code
GAG  
Date Received07/11/2016
Decision Date 11/17/2016
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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