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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, intravascular, diagnostic
510(k) Number K992631
Device Name ACUNAV DIAGNOSTIC ULTRASOUND CATHETER
Original Applicant
ACUSON CORP.
555 13th st., n.w.
washington,  DC  20004 1109
Original Contact howard m holstein
Regulation Number870.1200
Classification Product Code
DQO  
Subsequent Product Code
ITX  
Date Received08/06/1999
Decision Date 12/15/1999
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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