FDA 510(k) Application Details - K031328

Device Classification Name Filter, Intravascular, Cardiovascular

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510(K) Number K031328
Device Name Filter, Intravascular, Cardiovascular
Applicant C.R. BARD, INC.
1625 WEST 3RD ST.
TEMPE, AZ 85281-2438 US
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Contact Mary J Edwards
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Regulation Number 870.3375

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Classification Product Code DTK
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Date Received 04/28/2003
Decision Date 07/25/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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