FDA 510(k) Application Details - K024126

Device Classification Name Catheter, Intravascular, Diagnostic

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510(K) Number K024126
Device Name Catheter, Intravascular, Diagnostic
Applicant ABBOTT LABORATORIES
200 ABBOTT PARK RD.
D-389, BLDG J-45
ABBOTT PARK, IL 60064-3500 US
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Contact NICOHL R WILDING
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Regulation Number 870.1200

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Classification Product Code DQO
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Date Received 12/16/2002
Decision Date 01/14/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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