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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Uroflowmeter
510(k) Number K902408
Device Name DIAGNOSTIC ULTRASOUND UFS 1005
Applicant
DIAGNOSTIC ULTRASOUND CORP.
P.O. BOX 0789
KIRKLAND,  WA  98083 -0789
Applicant Contact GERALD MCMORROW
Correspondent
DIAGNOSTIC ULTRASOUND CORP.
P.O. BOX 0789
KIRKLAND,  WA  98083 -0789
Correspondent Contact GERALD MCMORROW
Regulation Number876.1800
Classification Product Code
EXY  
Date Received05/31/1990
Decision Date 08/10/1990
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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