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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 K103568
Models RAN1611, RPN1415
Device Name RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESH
Original Applicant
COLOPLAST A/S
1601 west river road north
minneapolis,  MN  55411
Original Contact janell a colley
Regulation Number878.3300
Classification Product Code
FTL  
Date Received12/06/2010
Decision Date 12/22/2010
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee Obstetrics/Gynecology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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