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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 K172361
Device Name EEA Circular Stapler with Tri-Staple Technology
Applicant
Covidien
Rooms 501, 502, 601, 602 No.3 building
No.2388, Chen Hang Road
Min Hang District, Shanghai,  CN 201114
Applicant Contact Sarah Tang
Correspondent
Covidien
Rooms 501, 502, 601, 602 No.3 building
No.2388, Chen Hang Road
Min Hang District, Shanghai,  CN 201114
Correspondent Contact Sarah Tang
Regulation Number878.4750
Classification Product Code
GDW  
Subsequent Product Code
GAG  
Date Received08/04/2017
Decision Date 02/16/2018
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
Recalls CDRH Recalls
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