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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 K993517
Device Name COMBISON 530D/VOLUSON 530D, TISSUE HARMONIC IMAGING (THI) OPTION
Applicant
Medison America, Inc.
6616 Owens Dr.
Pleasanton,  CA  94588
Applicant Contact GARY J ALLSEBROOK
Correspondent
Tuv Product Service, Inc.
1775 Old Hwy. 8
New Brighton,  MN  55112
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Codes
ITX   IYN  
Date Received10/18/1999
Decision Date 11/02/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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