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510(k) K090682

EDWARDS AQUARIUS SYSTEM, MODEL GE-F098-00 by Edwards Lifesciences Services GmbH — Product Code KDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 2009
Date Received
March 16, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device Class
Class II
Regulation Number
876.5860
Review Panel
GU
Submission Type

Other clearances by Edwards Lifesciences Services GmbH

  • K070320 — EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01 (June 7, 2007)
  • K063293 — EDWARDS AQUALINE STERILE TUBING SET; EDWARDS AQUALINS STERILE TUBING SET; EDWAR (March 23, 2007)

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  • K242053 — FX CorAL 40 (F00009214); FX CorAL 50 (F00009215) (March 21, 2025)