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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tray, catheterization, sterile urethral, with or without catheter (kit)
510(k) Number K070939
Device Name SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM
Applicant
COLOPLAST MANUFACTURING US, LLC
1601 WEST RIVER ROAD
MINNEAPOLIS,  MN  55411
Applicant Contact REBEKA STOLTMAN
Correspondent
COLOPLAST MANUFACTURING US, LLC
1601 WEST RIVER ROAD
MINNEAPOLIS,  MN  55411
Correspondent Contact REBEKA STOLTMAN
Regulation Number876.5130
Classification Product Code
FCM  
Date Received04/04/2007
Decision Date 06/01/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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