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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 K123066
Device Name ACCUMESH DEPLOYMENT SYSTEM
Applicant
Covidien, LLC
15 Crosby Dr.
Bedford,  MA  01730
Applicant Contact ELIZABETH MCMENIMAN
Correspondent
Covidien, LLC
15 Crosby Dr.
Bedford,  MA  01730
Correspondent Contact ELIZABETH MCMENIMAN
Regulation Number878.3300
Classification Product Code
ORQ  
Date Received10/01/2012
Decision Date 10/16/2012
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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