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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic, Diagnostic
510(k) Number K851036
Device Name SONOLAYER-V, SSA-90A
Applicant
Toshiba Medical Systems
2441 Michelle
P.O. Box 2068
Tustin,  CA  92680
Applicant Contact WYATT CANNADY
Correspondent
Toshiba Medical Systems
2441 Michelle
P.O. Box 2068
Tustin,  CA  92680
Correspondent Contact WYATT CANNADY
Regulation Number892.1570
Classification Product Code
ITX  
Date Received03/13/1985
Decision Date 09/17/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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