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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 K181620
Device Name Endoscopic Linear Cutting Staplers and Loading Units for Single Use
Applicant
Ezisurg (Suzhou) Medical Co., Ltd.
Bldg. 16, #8 Jinfeng Rd.
Suzhou National Hi-Tech District
Suzhou,  CN 215163
Applicant Contact Renjing Tian
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 Received06/20/2018
Decision Date 09/18/2018
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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