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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
Applicant
Sofradim Production
150 Glover Ave.
Norwalk,  CT  06856
Applicant Contact SHARON ALEXANDER
Correspondent
Sofradim Production
150 Glover Ave.
Norwalk,  CT  06856
Correspondent Contact SHARON ALEXANDER
Regulation Number884.5980
Classification Product Code
OTP  
Subsequent Product Code
OTO  
Date Received10/18/2007
Decision Date 12/19/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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