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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 K211197
Device Name Disposable Endoscopic Cutter Stapler and Cartridge
Applicant
Changzhou Waston Medical Appliance Co., Ltd.
9 Xihu Rd., Wujin Hi-Tech Industry Zone
Changzhou,  CN 213164
Applicant Contact Ning Mao
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 Received04/21/2021
Decision Date 01/19/2023
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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