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FDA 510(k) Application Details - K033436
Device Classification Name
More FDA Info for this Device
510(K) Number
K033436
Device Name
REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER
Applicant
ALLIANCE MEDICAL CORP.
10232 SOUTH 51ST ST.
PHOENIX, AZ 85044 US
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Contact
MOIRA BARTON
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Regulation Number
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Classification Product Code
OWQ
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Date Received
10/28/2003
Decision Date
03/16/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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