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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 K051503
Device Name UGYTEX SUAL KNIT MESH
Applicant
SOFRADIM PRODUCTION
5 WHITCOMB AVENUE
AYER,  MA  01432
Applicant Contact PAMELA PAPINEAU
Correspondent
SOFRADIM PRODUCTION
5 WHITCOMB AVENUE
AYER,  MA  01432
Correspondent Contact PAMELA PAPINEAU
Regulation Number884.5980
Classification Product Code
OTP  
Subsequent Product Codes
OTO   PAI   PAJ  
Date Received06/07/2005
Decision Date 08/05/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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