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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, imaging, pulsed doppler, ultrasonic
510(k) Number K032329
Device Name SA 9900 PLUS DIAGNOSTIC ULTRASOUND SYSTEM
Applicant
MEDISON AMERICA, INC.
11075 KNOTT AVE.
CYPRESS,  CA  90630
Applicant Contact A. ROBERT DEPALMA
Correspondent
TUV AMERICA, INC.
1775 OLD HIGHWAY 8
NEW BRIGHTON,  MN  55112 -1891
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received07/29/2003
Decision Date 08/06/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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