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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Urine Flow Rate Measuring, Non-Electrical, Disposable
510(k) Number K843441
Device Name URINARY DRAINAGE CONTAINER 2012-WITH
Applicant
VITALMETRICS, INC.
6341 NANCY RIDGE DRIVE
SAN DIEGO,  CA  92121 -
Applicant Contact ANNE WISTER
Correspondent
VITALMETRICS, INC.
6341 NANCY RIDGE DRIVE
SAN DIEGO,  CA  92121 -
Correspondent Contact ANNE WISTER
Regulation Number876.1800
Classification Product Code
FFG  
Date Received09/04/1984
Decision Date 01/03/1985
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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