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FDA 510(k) Application Details - K051319
Device Classification Name
More FDA Info for this Device
510(K) Number
K051319
Device Name
LYSUS INFUSION SYSTEM
Applicant
EKOS CORP.
22030 20TH AVENUE S.E.
SUITE 101
BOTHELL, WA 98021 US
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Contact
JOCELYN KERSTEN
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
QEY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/20/2005
Decision Date
06/15/2005
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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