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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
Original Applicant
SOFRADIM PRODUCTION
5 whitcomb avenue
ayer,  MA  01432
Original Contact pamela papineau
Regulation Number878.3300
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 General & Plastic Surgery
510k Review Panel General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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