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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 K211811
Device Name Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers
Applicant
Wuxi Beien Surgery Device Co., Ltd.
No.99 Furong San Road
Wuxi,  CN 214192
Applicant Contact Juan Li
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 Received06/11/2021
Decision Date 03/03/2022
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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