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510(k) K192978

EOGas 4 Ethylene Oxide Gas Sterilizer by Andersen Sterilizers, Inc. — Product Code FLF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 2020
Date Received
October 24, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer, Ethylene-Oxide Gas
Device Class
Class II
Regulation Number
880.6860
Review Panel
HO
Submission Type

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Other clearances for product code FLF

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  • K051595 — TSO3 OZONE STERILIZER, MODEL 125L (July 26, 2006)
  • K020875 — TSO3 OZONE STERILIZER, MODEL 125L (August 26, 2003)
  • K014013 — H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM (June 25, 2003)
  • K023290 — STERRAD 50 & STERRAD 100S STERILIZERS (April 3, 2003)
  • K923442 — ABTOX PLAZLYTE PROCESS MONITOR (December 22, 1994)
  • K905119 — PLAZLYTE(TM) (December 22, 1994)