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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 K131303
Device Name DISPOSABLE CIRCULAR STAPLER
Applicant
CHANGZHOU CITY ZHIYE MEDICAL DEVICES INSTITUTE CO.
12226 WASHINGTON LANE
PARKER,  AZ  85344
Applicant Contact CHARLIE MACK
Correspondent
CHANGZHOU CITY ZHIYE MEDICAL DEVICES INSTITUTE CO.
12226 WASHINGTON LANE
PARKER,  AZ  85344
Correspondent Contact CHARLIE MACK
Regulation Number878.4750
Classification Product Code
GDW  
Subsequent Product Code
GAG  
Date Received05/07/2013
Decision Date 06/11/2013
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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