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510(k) K941439

RENALIN COLD STERILANT by Minntech Corp. — Product Code LRJ

K941439 is an FDA 510(k) premarket notification submitted by Minntech Corp. for the device "RENALIN COLD STERILANT". The FDA issued a decision of Substantially Equivalent on June 26, 1995. The device falls under product code LRJ (Disinfectant, Medical Devices), a Class I device regulated under 21 CFR 880.6890. Minntech Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 1995
Date Received
March 24, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Disinfectant, Medical Devices
Device Class
Class I
Regulation Number
880.6890
Review Panel
HO
Submission Type

Other clearances by Minntech Corp.

  • K120306 — RAPICIDE OPA-28 (September 27, 2012)
  • 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)

Other clearances for product code LRJ

  • K992661 — CONTROL III ELITE (September 14, 1999)
  • K991509 — PRO-PORTION CLEANER/DISINFECTANT (July 14, 1999)
  • K984485 — MICROSTAT 2 (January 13, 1999)
  • K983947 — AMERSE 2 (December 4, 1998)
  • K983869 — DISPATCH HOSPITAL CLEANER DISINFECTANT TOWELS WITH BLEACH (November 30, 1998)
  • K983585 — LOW PH PHENOLIC 256 (November 6, 1998)
  • K982985 — CITREX HOSPITAL SPRAY DISINFECTANT (November 2, 1998)
  • K981023 — KLEENASEPTIC (April 30, 1998)
  • K980369 — T.B.Q. RTU (February 17, 1998)
  • K974304 — GERMICIDAL CLOTH (January 13, 1998)

FDA data resources