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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, polymeric
510(k) Number K121070
Device Name C-QUR RPM MESH
Original Applicant
ATRIUM MEDICAL CORP.
5 wentworth dr
hudson,  NH  03051
Original Contact joseph depaolo
Regulation Number878.3300
Classification Product Code
FTL  
Subsequent Product Code
OXA  
Date Received04/10/2012
Decision Date 04/26/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
statement statement
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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