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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 K033376
Device Name UGYTEX MESH
Original Applicant
SOFRADIM PRODUCTION
5 whitcomb avenue
ayer,  MA  01432
Original Contact mary mcnamara-cullinane
Regulation Number878.3300
Classification Product Code
FTL  
Date Received10/23/2003
Decision Date 01/15/2004
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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