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U.S. Department of Health and Human Services

Medical Devices

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List of FDA-Cleared Ethylene Oxide Sterilizers

510(k) Number Manufacture Device Name Sterilant

K014013

 

H W Technology, LLC H W Hospital Ethylene Oxide Sterilizer Ethylene Oxide

K941748

 

3M Health Care Steri-Vac Gas Sterilizer Model 8XL Ethylene Oxide

K931872

 

American Sterilizer Co. Eagle 3017 100% Ethylene Oxide Sterilizer Ethylene Oxide
K902036 3M Health Care Steri-Vac GAS Sterilizer Model 5XL Ethylene Oxide
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