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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 K103263
Device Name ENDO GIA SINGLEUSE DUET TRS RELOAD WITH TRI0STAPLE TECHNOLOGY
Applicant
COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H
60 Middletown Ave
North Haven,  CT  06473
Applicant Contact FRANK GIANELLI
Correspondent
COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H
60 Middletown Ave
North Haven,  CT  06473
Correspondent Contact FRANK GIANELLI
Regulation Number878.4750
Classification Product Code
GDW  
Date Received11/04/2010
Decision Date 11/22/2010
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
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