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FDA 510(k) Application Details - K031328
Device Classification Name
Filter, Intravascular, Cardiovascular
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
870.3375
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Classification Product Code
DTK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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