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FDA 510(k) Application Details - K080392
Device Classification Name
More FDA Info for this Device
510(K) Number
K080392
Device Name
EndoWave Infusion System
Applicant
EKOS CORP.
11911 N CREEK PARKWAY SOUTH
BOTHELL, WA 98011 US
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Contact
JOCELYN KERSTEN
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Regulation Number
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Classification Product Code
QEY
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Date Received
02/13/2008
Decision Date
04/30/2008
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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