FDA 510(k) Application Details - K002006

Device Classification Name Set, Administration, Intravascular

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510(K) Number K002006
Device Name Set, Administration, Intravascular
Applicant ABBOTT LABORATORIES
DEPT. 389, AP30
200 ABBOTT PARK RD.
ABBOTT PARK, IL 60064-3537 US
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Contact THOMAS P SAMPOGNA
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Regulation Number 880.5440

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Classification Product Code FPA
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Date Received 07/03/2000
Decision Date 08/10/2000
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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