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FDA 510(k) Application Details - K090682
Device Classification Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
More FDA Info for this Device
510(K) Number
K090682
Device Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant
EDWARDS LIFESCIENCES SERVICES GMBH
BIOPARK
BROADWATER ROAD
WELWYN GARDEN CITY AL7 3AX GB
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Contact
NEIL R ARMSTRONG
Other 510(k) Applications for this Contact
Regulation Number
876.5860
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Classification Product Code
KDI
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More FDA Info for this Product Code
Date Received
03/16/2009
Decision Date
11/19/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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