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510(k) K991851

RENACLEAR DIALYZER CLEANING SYSTEM by Minntech Corp. — Product Code LIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 1999
Date Received
June 1, 1999
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

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  • K983126 — FIBERFLO HOLLOW FIBER CAPSULE WATER FILTERS (March 8, 1999)
  • K983085 — HEMOCOR HPH 700 HEMOCONCENTRATOR (November 13, 1998)

Other clearances for product code LIF

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  • 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)
  • K974426 — POTENCY TEST STRIPS, INDICATOR TEST STRIPS (February 10, 1999)
  • K974798 — STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS (March 20, 1998)
  • K970799 — ALEXANDER MANUFACTURING RECHARGEABLE BATTERY (M1/T) (May 14, 1997)