FDA 510(k) Application Details - K031783

Device Classification Name Set, Administration, Intravascular

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510(K) Number K031783
Device Name Set, Administration, Intravascular
Applicant INTRAVASCULAR INCORPORATED
3600 BUR WOOD DR.
WAUKEGAN, IL 60085 US
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Contact STEVE APERAVICH
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Regulation Number 880.5440

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Classification Product Code FPA
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Date Received 06/10/2003
Decision Date 07/01/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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