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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, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed
510(k) Number K072951
Device Name PARIETENE DUO AND QUADRA POLYPROPYLENE MESHES
Original Applicant
SOFRADIM PRODUCTION
150 glover avenue
norwalk,  CT  06856
Original Contact sharon alexander
Regulation Number878.3300
Classification Product Code
OTP  
Subsequent Product Code
OTO  
Date Received11/19/2007
Decision Date 12/19/2007
Decision substantially equivalent (SE)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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