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FDA 510(k) Application Details - K020316
Device Classification Name
Catheter, Intravascular, Diagnostic
More FDA Info for this Device
510(K) Number
K020316
Device Name
Catheter, Intravascular, Diagnostic
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
870.1200
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Classification Product Code
DQO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/30/2002
Decision Date
03/20/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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