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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 stress urinary incontinence, female, mini-sling
510(k) Number K063136
Device Name NEEDLELESS SLING
Applicant
SPECIALITIES REMEEX INTERNATIONAL, S.L.
7307 glouchester drive
edina,  MN  55435
Applicant Contact jeffrey r shideman
Correspondent
SPECIALITIES REMEEX INTERNATIONAL, S.L.
7307 glouchester drive
edina,  MN  55435
Correspodent Contact jeffrey r shideman
Regulation Number878.3300
Classification Product Code
PAH  
Date Received10/16/2006
Decision Date 12/19/2006
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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