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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 K012867
Device Name SONOACE 9900 DIAGNOSTIC ULTRASOUND SYSTEM
Applicant
MEDISON AMERICA, INC.
16303 PANORAMIC WAY
SAN LEANDRO,  CA  94578 -1116
Applicant Contact GARY J ALLSEBROOK
Correspondent
TUV PRODUCT SERVICE, INC.
1775 OLD HIGHWAY 8
NEW BRIGHTON,  MN  55112 -1891
Correspondent Contact MARK JOB
Regulation Number892.1550
Classification Product Code
IYN  
Date Received08/27/2001
Decision Date 09/12/2001
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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