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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 K130782
Device Name ACCUMESH DEPLOYMENT SYSTEM
Applicant
Covidien LLC
15 CROSBY DRIVE
BEDFORD,  MA  01730
Applicant Contact JOSE MARQUEZ
Correspondent
Covidien LLC
15 CROSBY DRIVE
BEDFORD,  MA  01730
Correspondent Contact JOSE MARQUEZ
Regulation Number878.3300
Classification Product Code
ORQ  
Date Received03/21/2013
Decision Date 04/05/2013
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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