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FDA 510(k) Application Details - K062429
Device Classification Name
Filter, Blood, Cardiopulmonary Bypass, Arterial Line
More FDA Info for this Device
510(K) Number
K062429
Device Name
Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Applicant
EDWARDS LIFESCIENCES RESEARCH MEDICAL
6864 SOUTH 300 WEST
MIDVALE, UT 84047 US
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Contact
KAREN JONES
Other 510(k) Applications for this Contact
Regulation Number
870.4260
More FDA Info for this Regulation Number
Classification Product Code
DTM
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More FDA Info for this Product Code
Date Received
08/21/2006
Decision Date
09/27/2006
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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