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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cystometric gas (carbon-dioxide) on hydraulic device
510(k) Number K911125
Device Name DIAGNOSTIC ULTRASOUND/URO-GYN UPS 2020
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 Number876.1620
Classification Product Code
FAP  
Date Received03/13/1991
Decision Date 08/15/1991
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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