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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 K192330
Device Name EEA Circular 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 Sarah Tang
Correspondent
Covidien
60 Middletown Ave.
North Haven,  CT  06473
Correspondent Contact Frank Gianelli
Regulation Number878.4750
Classification Product Code
GDW  
Date Received08/27/2019
Decision Date 01/23/2020
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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