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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K863236
Device Name ACUSON S519B 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
Date Received08/21/1986
Decision Date 02/13/1987
Decision Substantially Equivalent (SESE)
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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