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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, Retropubic Or Transobturator
510(k) Number K033310
Device Name REMEEX SYSTEM FOR URINARY INCONTINENCE
Applicant
Specialities Remeex International, S.L.
7307 Glouchester Dr.
Minneapolis,  MN  55435
Applicant Contact JEFFREY R SHIDEMAN
Correspondent
Specialities Remeex International, S.L.
7307 Glouchester Dr.
Minneapolis,  MN  55435
Correspondent Contact JEFFREY R SHIDEMAN
Regulation Number878.3300
Classification Product Code
OTN  
Date Received10/14/2003
Decision Date 01/15/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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