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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
Other 510(k) Applications for this Contact
Regulation Number
892.1570
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Classification Product Code
ITX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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