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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transport Systems, Anaerobic
510(k) Number K897151
Device Name ACUSON V328 AND C5432 TRANSDUCERS
Applicant
Acuson Corp.
1220 Charleston Rd.
Mountain View,  CA  94039 -7393
Applicant Contact STEPHEN T JOHNSON
Correspondent
Acuson Corp.
1220 Charleston Rd.
Mountain View,  CA  94039 -7393
Correspondent Contact STEPHEN T JOHNSON
Regulation Number866.2900
Classification Product Code
JTX  
Date Received12/26/1989
Decision Date 07/03/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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