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510(k) K944492

DIALYZER REPROCESSING SYSTEM by G.E.M. Water Systems — Product Code LIF

K944492 is an FDA 510(k) premarket notification submitted by G.E.M. Water Systems for the device "DIALYZER REPROCESSING SYSTEM". The FDA issued a decision of Substantially Equivalent on August 28, 1995. The device falls under product code LIF (Dialyzer Reprocessing System), a Class II device regulated under 21 CFR 876.5820. G.E.M. Water Systems has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 1995
Date Received
September 13, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialyzer Reprocessing System
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by G.E.M. Water Systems

  • K970674 — G.E.M. WATER SYSTEMS, INTERNATIONAL (November 19, 1997)
  • K944493 — REVERSE OSMOSIS SYSTEM (February 20, 1996)

Other clearances for product code LIF

  • K091360 — CLEARFLUX DIALYZER REPROCESSING SYSTEM (November 3, 2010)
  • K043126 — ASSIST HEADER CLEANER (February 3, 2005)
  • K040660 — STERICHEK GLUTARALDEHYDE REAGENT STRIPS (November 15, 2004)
  • K033505 — RENACLEAN SH DIALYZER CLEANING SYSTEM (April 27, 2004)
  • K024076 — MAKY 21.1 DIALYZER REPROCESSING SYSTEM (September 26, 2003)
  • K013713 — ARM AUTOMATIC REPROCESSING MACHINE (July 15, 2002)
  • K992016 — AMUKIN D (January 10, 2000)
  • K991851 — RENACLEAR DIALYZER CLEANING SYSTEM (August 30, 1999)
  • K974426 — POTENCY TEST STRIPS, INDICATOR TEST STRIPS (February 10, 1999)
  • K974798 — STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS (March 20, 1998)

FDA data resources