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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Urinometer, Mechanical
510(k) Number K761083
Device Name BARD URINE METER W/ 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 Number876.1800
Classification Product Code
EXR  
Date Received11/19/1976
Decision Date 01/26/1977
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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