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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 K860531
Device Name SONOLAYER-L, SAL-38A, WITH SCANNER SAL-38AS
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 Received02/12/1986
Decision Date 07/18/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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