FDA 510(k) Application Details - K090134

Device Classification Name Set, Administration, Intravascular

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510(K) Number K090134
Device Name Set, Administration, Intravascular
Applicant C.R. BARD, INC.
8195 INDUSTRIAL BLVD.
COVINGTON, GA 30014 US
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Contact SCOTT PEASE
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Regulation Number 880.5440

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Classification Product Code FPA
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Date Received 01/21/2009
Decision Date 04/21/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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