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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Probe, Blood-Flow, Extravascular
510(k) Number K874861
Device Name ACUSON S328 TRANSDUCER FOR CARDIAC COLOR FLOW APP.
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 Number870.2120
Classification Product Code
DPT  
Date Received11/27/1987
Decision Date 05/11/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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