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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, urethral
510(k) Number K143182
FOIA Releasable 510(k) K143182
Device Name Speedicath Compact Male
Applicant
COLOPLAST A/S
1601 WEST RIVER ROAD NORTH
MINNEAPOLIS,  MN  55411
Applicant Contact Brian Schmidt
Correspondent
COLOPLAST A/S
1601 WEST RIVER ROAD NORTH
MINNEAPOLIS,  MN  55411
Correspondent Contact Brian Schmidt
Regulation Number876.5130
Classification Product Code
GBM  
Date Received11/05/2014
Decision Date 01/20/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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