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510(k) K192978

Device
EOGas 4 Ethylene Oxide Gas Sterilizer
Applicant
Andersen Sterilizers, Inc.
510(k) number
K192978
Product code
FLF
Decision
Substantially Equivalent (SESE)
Decision date
2020-11-12
Date received
2019-10-24
Regulation
880.6860
Classification name
Sterilizer, Ethylene-Oxide Gas
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
William K. Andersen
Address
3154 Caroline Dr. Haw River NC US 27258 27258

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FLF#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K170432Anprolene AN75 Ethylene Oxide Gas SterilizerAndersen Sterilizers, Inc.2017-10-31
K150646EOGas 4 Ethylene Oxide Gas SterilizerAndersen Sterilizers, Inc.2015-11-18
K1420343M STERI-VAC STERILIZER/AERATOR3M Company2015-01-08
K090636TSO3 OZONE STERILIZER, MODEL 125LTso3, Inc.2009-12-02
K051595TSO3 OZONE STERILIZER, MODEL 125LTso3, Inc.2006-07-26
K020875TSO3 OZONE STERILIZER, MODEL 125LTechnologies of Sterilization With Oxone, Tso3, Inc.2003-08-26
K014013H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEMH & W Technology, LLC2003-06-25
K023290STERRAD 50 & STERRAD 100S STERILIZERSAdvanced Sterilization Products2003-04-03
K923442ABTOX PLAZLYTE PROCESS MONITORAbtox, Inc.1994-12-22
K905119PLAZLYTE(TM)Abtox, Inc.1994-12-22
K941748STERI-VAC GAS STERILIZER MODEL 8XL3M Health Care, Ltd.1994-12-02
K931872THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZERAmerican Sterilizer Co.1994-02-07
K915682STERRAD 100 STERILIZATION SYSTEMJohnson & Johnson Medical, Inc.1993-10-01
K920930MDT/CASTLE 10/90 DUAL LOAD STATIONMdt Corp., Inc.1993-03-31
K910649MDT/CASTLE 10/90 LOAD STATIONMdt Biologic Co.1991-09-06