FDA 510(k) Application Details - K033436

Device Classification Name

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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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