FDA 510(k) Application Details - K001872

Device Classification Name Set, Administration, Intravascular

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510(K) Number K001872
Device Name Set, Administration, Intravascular
Applicant CODAN US CORP.
15412 VERDUN CIRCLE
IRVINE, CA 92604 US
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Contact RICHARD A BASLER
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Regulation Number 880.5440

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Classification Product Code FPA
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Date Received 06/20/2000
Decision Date 09/07/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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