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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 K111825
Device Name ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS, DST SERIES(TM) TA(TM) STAPLERS
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 Received06/28/2011
Decision Date 10/25/2011
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
Recalls CDRH Recalls
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