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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name bag, urine collection, leg, for external use, sterile
510(k) Number K780032
Device Name URINARY LEG BAG
Applicant
C.R. BARD, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
C.R. BARD, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.5250
Classification Product Code
FAQ  
Date Received01/09/1978
Decision Date 01/17/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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