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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 K854786
Device Name ACUSON BL538 TRANSDUCER
Applicant
Acuson Computed Sonography
1220 Charleston Rd.
P.O. Box 7393
Mountain View,  CA  94039
Applicant Contact ROBERT J GALLAGHER
Correspondent
Acuson Computed Sonography
1220 Charleston Rd.
P.O. Box 7393
Mountain View,  CA  94039
Correspondent Contact ROBERT J GALLAGHER
Regulation Number892.1570
Classification Product Code
ITX  
Date Received11/29/1985
Decision Date 01/15/1986
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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