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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector And Syringe, Angiographic
510(k) Number K911166
Device Name DIAGNOSTIC ULTRASOUND/URO-GYN UD 511
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 Number870.1650
Classification Product Code
DXT  
Date Received03/15/1991
Decision Date 08/15/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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