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FDA 510(k) Application Details - K093730
Device Classification Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
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510(K) Number
K093730
Device Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant
EDWARDS LIFESCIENCES, LLC.
6864 SOUTH 300 WEST
MIDVALE, UT 84047 US
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Contact
SPENCER WALKER
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Regulation Number
870.4210
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Classification Product Code
DWF
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More FDA Info for this Product Code
Date Received
12/03/2009
Decision Date
01/14/2010
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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