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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name appliance, colostomy, disposable
510(k) Number K780409
Device Name COLOPLAST-DURASEAL OSTOMY APPLIANCE
Applicant
C.R. BARD, INC.
110 MARSHALL DRIVE
WARRANDALE,  PA  15086
Correspondent
C.R. BARD, INC.
110 MARSHALL DRIVE
WARRANDALE,  PA  15086
Regulation Number876.5900
Classification Product Code
EZS  
Date Received03/13/1978
Decision Date 04/27/1978
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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