FLF — Sterilizer, Ethylene-Oxide Gas Class II

FDA Device Classification

Classification Details

Product Code
FLF
Device Class
Class II
Regulation Number
880.6860
Submission Type
Review Panel
HO
Medical Specialty
General Hospital
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K192978andersen sterilizersEOGas 4 Ethylene Oxide Gas SterilizerNovember 12, 2020
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K014013h and w technologyH & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEMJune 25, 2003
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K923442abtoxABTOX PLAZLYTE PROCESS MONITORDecember 22, 1994
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K931872american sterilizerTHE EAGLE 3017 100% ETHYLENE OXIDE STERILIZERFebruary 7, 1994
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K920930mdt corpMDT/CASTLE 10/90 DUAL LOAD STATIONMarch 31, 1993
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K852115ars enterprisesARS ENTERPRISES ETHYLENE OXIDE GAS STERILIZERNovember 1, 1985