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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Collector, Urine, (And Accessories) For Indwelling Catheter
510(k) Number K854580
Device Name CONVEEN SELF-SEALING URISHEATH MALE EXTERNAL CATH
Applicant
Coloplast A/S
C/O Richard Hamer Assoc.Inc.
P.O.Box 16598
Fort Woth,  TX  76162
Applicant Contact C/O R HAMMER/ASSOCI
Correspondent
Coloplast A/S
C/O Richard Hamer Assoc.Inc.
P.O.Box 16598
Fort Woth,  TX  76162
Correspondent Contact C/O R HAMMER/ASSOCI
Regulation Number876.5250
Classification Product Code
KNX  
Date Received11/15/1985
Decision Date 12/13/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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