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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 K023254
FOIA Releasable 510(k) K023254
Device Name SPEEDICATH
Applicant
Coloplast Corp.
1940 Commerce Dr.
North Mankato,  MN  56003
Applicant Contact ELIZABETH BOOTS
Correspondent
Coloplast Corp.
1940 Commerce Dr.
North Mankato,  MN  56003
Correspondent Contact ELIZABETH BOOTS
Regulation Number876.5130
Classification Product Code
GBM  
Date Received09/30/2002
Decision Date 01/27/2003
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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