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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 K133938
Device Name ENDO GIA REINFORCED RELOAD WITH TRI-STAPLE TECHNOLOGY
Applicant
COVIDIEN
15 HAMPSHIRE STREET
MANSFIELD,  MA  02048
Applicant Contact JOSE MARQUEZ
Correspondent
COVIDIEN
15 HAMPSHIRE STREET
MANSFIELD,  MA  02048
Correspondent Contact JOSE MARQUEZ
Regulation Number878.4750
Classification Product Code
GDW  
Subsequent Product Code
ORQ  
Date Received12/23/2013
Decision Date 01/22/2014
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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