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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 K140609
Device Name RELIATACK ARTICULATING RELOADABLE FIXATION DEVICE WITH STANDARD PURCHASE ABSORBLE TACKS
Applicant
Covidien
60 Middletown Ave.
North Haven,  CT  06473
Applicant Contact CLARE SANTULLI
Correspondent
Covidien
60 Middletown Ave.
North Haven,  CT  06473
Correspondent Contact CLARE SANTULLI
Regulation Number878.4750
Classification Product Code
GDW  
Date Received03/10/2014
Decision Date 04/09/2014
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
Predetermined Change
Control Plan Authorized		 No
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