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510(k) K023615

GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR by Gambro Renal Products — Product Code MSF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 2003
Date Received
October 28, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemodialyzer, Re-Use, High Flux
Device Class
Class II
Regulation Number
876.5860
Review Panel
GU
Submission Type

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