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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 K844338
Device Name 1URO-LOG HOME DIAGNOSTIC PACK
Applicant
Epcom Medical Systems, Inc.
26602 Corporate Ave.
Hayward,  CA  94545
Applicant Contact PAUL ULBRICH
Correspondent
Epcom Medical Systems, Inc.
26602 Corporate Ave.
Hayward,  CA  94545
Correspondent Contact PAUL ULBRICH
Regulation Number876.1800
Classification Product Code
FFG  
Date Received11/08/1984
Decision Date 02/25/1985
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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