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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Urological
510(k) Number K895548
Device Name CONVEEN INTERMITTENT CATHETERS
Applicant
COLOPLAST A/S
C/O RICHARD HAMER ASSOC., INC.
P.O. BOX 16598
FT. WORTH,  TX  76162
Applicant Contact RICHARD A HAMER
Correspondent
COLOPLAST A/S
C/O RICHARD HAMER ASSOC., INC.
P.O. BOX 16598
FT. WORTH,  TX  76162
Correspondent Contact RICHARD A HAMER
Regulation Number876.5130
Classification Product Code
KOD  
Date Received09/13/1989
Decision Date 02/09/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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