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510(k) K852115

Device
ARS ENTERPRISES ETHYLENE OXIDE GAS STERILIZER
Applicant
ARS ENTERPRISES, INC.
510(k) number
K852115
Product code
FLF  
Decision
Substantially Equivalent (SESE)
Decision date
1985-11-01
Date received
1985-05-15
Regulation
880.6860
Classification name
Sterilizer, Ethylene-oxide Gas
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ELEANOR WANNER
Address
12900 Lakeland Rd. Santa Fe Springs CA US 90670 90670

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FLF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K192978EOGas 4 Ethylene Oxide Gas SterilizerAndersen Sterilizers, Inc.2020-11-12
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

Legacy Summary#

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FDA Review#

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