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FDA 510(k) Application Details - K090255
Device Classification Name
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
More FDA Info for this Device
510(K) Number
K090255
Device Name
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Applicant
NXSTAGE MEDICAL, INC.
439 SOUTH UNION ST., 5TH FLOOR
LAWRENCE, MA 01843 US
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Contact
MICHAEL DOYLE
Other 510(k) Applications for this Contact
Regulation Number
876.5820
More FDA Info for this Regulation Number
Classification Product Code
FJK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/02/2009
Decision Date
02/10/2009
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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