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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 K132493
Device Name ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY
Applicant
Covidien LLC
60 MIDDLETOWN AVENUE
NORTH HAVEN,  CT  06473
Applicant Contact KATHERINE KASSIM
Correspondent
Covidien LLC
60 MIDDLETOWN AVENUE
NORTH HAVEN,  CT  06473
Correspondent Contact KATHERINE KASSIM
Regulation Number878.4750
Classification Product Code
GDW  
Date Received08/09/2013
Decision Date 10/23/2013
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
Recalls CDRH Recalls
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