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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 K991710
Device Name SSA-370A/POWERVISION 6000
Applicant
Toshiba America Medical Systems, In.C
2441 Michelle Dr.
P.O. Box 2068
Tustin,  CA  92781
Applicant Contact PAUL BIGGINS
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 Received05/19/1999
Decision Date 06/03/1999
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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