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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 K182476
Device Name Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads
Applicant
Fengh Medical Co., Ltd.
D3 # 6 Dongsheng W. Rd.
Jiangyin National High-Tech Zone
Wuxi,  CN 214437
Applicant Contact Jiao Liu
Correspondent
Fengh Medical Co., Ltd.
D3 # 6 Dongsheng W. Rd.
Jiangyin National High-Tech Zone
Wuxi,  CN 214437
Correspondent Contact Jiao Liu
Regulation Number878.4750
Classification Product Code
GDW  
Date Received09/10/2018
Decision Date 12/18/2019
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
Predetermined Change
Control Plan Authorized		 No
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