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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, deployer
510(k) Number K121139
Model TBD
Device Name ACCUMESH DEPLOYMENT SYSTEM
Original Applicant
COVIDIEN LLC
15 crosby dr
bedford,  MA  01730
Original Contact james mcmahon
Regulation Number878.3300
Classification Product Code
ORQ  
Date Received04/16/2012
Decision Date 05/02/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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