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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 Echo, Ultrasonic
510(k) Number K000030
Device Name SONOACE 600 DIAGNOSTIC ULTRASOUND SYSTEM
Applicant
Medison America, Inc.
6616 Owens Dr.
Pleasanton,  CA  94588
Applicant Contact GARY J ALLESBROOK
Correspondent
Tuv Product Service, Inc.
1775 Old Highway 8
New Brighton,  MN  55112 -1891
Correspondent Contact CAROLE STAMP
Regulation Number892.1560
Classification Product Code
IYO  
Date Received01/05/2000
Decision Date 01/19/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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