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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 K133762
Device Name ENDO GIA(TM) EXTRA LONG ADAPTER
Applicant
Covidien LLC
60 MIDDLETOWN AVENUE
NORTH HAVEN,  CT  06473
Applicant Contact DEBRA PEACOCK
Correspondent
Covidien LLC
60 MIDDLETOWN AVENUE
NORTH HAVEN,  CT  06473
Correspondent Contact DEBRA PEACOCK
Regulation Number878.4750
Classification Product Code
GDW  
Date Received12/11/2013
Decision Date 01/08/2014
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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