FDA 510(k) Application Details - K033576

Device Classification Name Set, Administration, Intravascular

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510(K) Number K033576
Device Name Set, Administration, Intravascular
Applicant ABBOTT LABORATORIES
DEPT. 389, BLDG. J45-2N
200 ABBOTT PARK ROAD
ABBOTT PARK, IL 60064-6133 US
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Contact PATRICIA MELERSKI
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Regulation Number 880.5440

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Classification Product Code FPA
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Date Received 11/13/2003
Decision Date 12/04/2003
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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