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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Paste-On For Incontinence, Sterile
510(k) Number K915246
Device Name CONVEEN(R) URISHEATH AND URILINER(MALE EXTER CATH)
Applicant
Coloplast A/S
C/O Richard Hamer Assoc.Inc.
P.O.Box 16598
Fort Woth,  TX  76162
Applicant Contact RICHARD A HAMER
Correspondent
Coloplast A/S
C/O Richard Hamer Assoc.Inc.
P.O.Box 16598
Fort Woth,  TX  76162
Correspondent Contact RICHARD A HAMER
Regulation Number876.5250
Classification Product Code
EXI  
Date Received11/15/1991
Decision Date 02/05/1992
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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