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510(k) K130039

REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER by Gambro Renal Products, Inc. — Product Code KDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2013
Date Received
January 7, 2013
Clearance Type
Traditional
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 Gambro Renal Products, Inc.

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  • K131516 — PRISMAFLEX SYSTEM 7.10 (January 3, 2014)
  • K113313 — MOLECULAR ADSORBENT RECIRCULATING(MARS) (December 14, 2012)
  • K120333 — PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEMENT THERAPY (May 25, 2012)
  • K110823 — PRISMAFLEX (June 17, 2011)
  • K103832 — PHOENIX HEMODIALYSIS DELIVERY SYSTEM (May 20, 2011)
  • K100451 — GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW (December 21, 2010)
  • K100364 — GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520 (November 3, 2010)
  • K093608 — GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H (July 29, 2010)
  • K080519 — PRISMAFLEX M150 SET (June 13, 2008)

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