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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name mesh, surgical
510(k) Number K120605
Device Name PERMACOL SURGICAL IMPLANT
Original Applicant
COVIDIEN LLC
15 crosby dr
bedford,  MA  01730
Original Contact james mcmahon
Regulation Number878.3300
Classification Product Code
FTM  
Subsequent Product Code
OXK  
Date Received02/28/2012
Decision Date 05/18/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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