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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 K202701
Device Name GIA Stapler with Tri-Staple Technology
Applicant
Covidien
Rm.s 501,502,601,602, #3 Bldg., #2388 Chen Hang Rd.
Min Hang District, Shanghai,  CN 201114
Applicant Contact Leo Chen
Correspondent
Covidien
60 Middletown Ave.
North Haven,  CT  06473
Correspondent Contact Katherine Y. Choi
Regulation Number878.4750
Classification Product Code
GDW  
Date Received09/16/2020
Decision Date 12/07/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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