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FDA 510(k) Application Details - K071529
Device Classification Name
More FDA Info for this Device
510(K) Number
K071529
Device Name
XTRACT CATHETER SYSTEM
Applicant
LUMEN BIOMEDICAL, INC.
14505 21ST AVE. NORTH
SUITE 212
PLYMOUTH, MN 55447 US
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Contact
MARIA E BRITTLE
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QEZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/05/2007
Decision Date
08/10/2007
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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