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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, For Stress Urinary Incontinence, Male
510(k) Number K062341
Device Name MALE REMEEX SYSTEM
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
Correspondent Contact JEFFREY R SHIDEMAN
Regulation Number878.3300
Classification Product Code
OTM  
Date Received08/10/2006
Decision Date 11/02/2006
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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