FDA 510(k) Application Details - K030002

Device Classification Name Set, Administration, Intravascular

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510(K) Number K030002
Device Name Set, Administration, Intravascular
Applicant ABBOTT LABORATORIES
D-389, BLDG. J45-2
200 ABBOTT PARK ROAD
ABBOTT PARK, IL 60064-6157 US
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Contact NOCOHL R WILDING
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Regulation Number 880.5440

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Classification Product Code FPA
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Date Received 01/02/2003
Decision Date 01/27/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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