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510(k) K951983

IMNI-II by Cottrell, Ltd. — Product Code LRJ

K951983 is an FDA 510(k) premarket notification submitted by Cottrell, Ltd. for the device "IMNI-II". The FDA issued a decision of Substantially Equivalent on June 20, 1995. The device falls under product code LRJ (Disinfectant, Medical Devices), a Class I device regulated under 21 CFR 880.6890. Cottrell, Ltd. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 1995
Date Received
April 27, 1995
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 Cottrell, Ltd.

  • K972708 — ENDO-SPOR PLUS / HYPROCIDE (September 13, 1999)
  • K970726 — VAPOCIDE (May 18, 1998)
  • K960089 — PROCHEK G GLUTARALDEHYDE CONCENTRATION LEVEL INDICATOR (April 4, 1996)
  • K952241 — PROTOUCH OVERGLOVE (August 7, 1995)
  • K952234 — BARRIER ALL FILM (July 31, 1995)
  • K932922 — PROCIDE 14 N.S., OMNICIDE/LIQUID & PLUS LIQ ACTIVATOR (July 3, 1995)
  • K945575 — PRO BARRIER(TM) TUBE SOX(TM) (March 6, 1995)
  • K893802 — PROVIEW SELF-SEALING STERILIZATION POUCH (April 4, 1990)

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