FDA 510(k) Application Details - K031920

Device Classification Name Transducer, Ultrasonic, Diagnostic

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510(K) Number K031920
Device Name Transducer, Ultrasonic, Diagnostic
Applicant TRANS VASCULAR INCORPORATED
1505-D ADAMS DR.
MENLO PARK, CA 94925 US
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Contact RICHARD E ANDERSON
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Regulation Number 892.1570

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Classification Product Code ITX
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Date Received 06/23/2003
Decision Date 07/23/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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