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FDA 510(k) Application Details - K001283
Device Classification Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
More FDA Info for this Device
510(K) Number
K001283
Device Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant
NXSTAGE MEDICAL, INC.
3 HIGHWOOD DR.
TEWKSBURY, MA 01876 US
Other 510(k) Applications for this Company
Contact
JEFFREY BURBANK
Other 510(k) Applications for this Contact
Regulation Number
876.5860
More FDA Info for this Regulation Number
Classification Product Code
KDI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/21/2000
Decision Date
01/17/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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