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FDA 510(k) Application Details - K003964
Device Classification Name
Filter, Intravascular, Cardiovascular
More FDA Info for this Device
510(K) Number
K003964
Device Name
Filter, Intravascular, Cardiovascular
Applicant
CORDIS CORP.
7 POWDER HORN DR.
WARREN, NJ 07059 US
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Contact
KAREN WILK
Other 510(k) Applications for this Contact
Regulation Number
870.3375
More FDA Info for this Regulation Number
Classification Product Code
DTK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/22/2000
Decision Date
01/19/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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