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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 K161757
Device Name Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear Cutters and Reloads, Single Use Endoscopic Linear Cutters and Reloads, Single Use Hemorrhoidal Staplers, Single Use Linear Staplers and Reloads
Applicant
VICTOR MEDICAL INSTRUMENTS CO.,LTD.
NO.21, HUAFENG RD, QISHUYAN DISTRICT
Changzhou,  CN 213018
Applicant Contact Yunhuo Chen
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 Received06/27/2016
Decision Date 12/05/2016
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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