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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Transducer, Ultrasonic
510(k) Number K842539
Device Name DIAGNOSTIC ULTRASOUND 105 & 110
Applicant
Diagnostic Ultrasound Corp.
P.O. Box 0789
Kirkland,  WA  98083
Applicant Contact GERALD MCMORROW
Correspondent
Diagnostic Ultrasound Corp.
P.O. Box 0789
Kirkland,  WA  98083
Correspondent Contact GERALD MCMORROW
Regulation Number870.2880
Classification Product Code
JOP  
Date Received06/28/1984
Decision Date 04/10/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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