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FDA 510(k) Application Details - K023116
Device Classification Name
Filter, Intravascular, Cardiovascular
More FDA Info for this Device
510(K) Number
K023116
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
09/19/2002
Decision Date
10/18/2002
Decision
SESU - SE - WITH LIMITATIONS
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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