FDA 510(k) Applications for Medical Device Product Code "FLF"
(Sterilizer, Ethylene-Oxide Gas)

FDA 510(k) Number Applicant Device Name Decision Date
K142034 3M COMPANY 3M STERI-VAC STERILIZER/AERATOR 01/08/2015
K023290 ADVANCED STERILIZATION PRODUCTS STERRAD 50 & STERRAD 100S STERILIZERS 04/03/2003
K170432 Andersen Sterilizers, Inc. Anprolene AN75 Ethylene Oxide Gas Sterilizer 10/31/2017
K150646 ANDERSEN STERILIZERS, INC. EOGas 4 Ethylene Oxide Gas Sterilizer 11/18/2015
K192978 Andersen Sterilizers, Inc. EOGas 4 Ethylene Oxide Gas Sterilizer 11/12/2020
K014013 H & W TECHNOLOGY, LLC H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM 06/25/2003
K020875 TECHNOLOGIES OF STERILIZATION WITH OXONE, TSO3 INC TSO3 OZONE STERILIZER, MODEL 125L 08/26/2003
K051595 TSO3 INC. TSO3 OZONE STERILIZER, MODEL 125L 07/26/2006
K090636 TSO3 INC. TSO3 OZONE STERILIZER, MODEL 125L 12/02/2009


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact