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510(k) K980859

HEMOCOR HPH MINI HEMOCONCENTRATOR by Minntech Corp. — Product Code KDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 1998
Date Received
March 5, 1998
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 Minntech Corp.

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  • K092387 — MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEM (April 5, 2010)
  • K071298 — HF JUNIOR HEMOFILTER (August 8, 2007)
  • K050952 — HPH JUNIOR HIGH PERFORMANCE HEMOCONCENTRATOR (January 31, 2006)
  • K033505 — RENACLEAN SH DIALYZER CLEANING SYSTEM (April 27, 2004)
  • K014016 — ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER (February 1, 2002)
  • K991137 — ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER (June 8, 2000)
  • K000028 — RENAFLO II HF 2000 HEMOFILTER (April 4, 2000)
  • K991851 — RENACLEAR DIALYZER CLEANING SYSTEM (August 30, 1999)
  • K983126 — FIBERFLO HOLLOW FIBER CAPSULE WATER FILTERS (March 8, 1999)

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