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510(k) K992631

ACUNAV DIAGNOSTIC ULTRASOUND CATHETER by Acuson Corp. — Product Code DQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 1999
Date Received
August 6, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Diagnostic
Device Class
Class II
Regulation Number
870.1200
Review Panel
CV
Submission Type

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  • K973767 — HARMONIC IMAGING WITH CONTRAST (December 23, 1997)
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