BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    STERI-VAC GAS STERILIZER MODEL 8XL

    K Number: K941748 · Decision Dec 2, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    25
    Applicant Total
    49
    Review Days
    238

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    Basic Information

    Device Name
    STERI-VAC GAS STERILIZER MODEL 8XL
    K Number
    K941748
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    3M Health Care, Ltd.
    Date Received
    April 8, 1994
    Decision Date
    December 2, 1994
    Product Code
    FLF
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FLF Sterilizer, Ethylene-Oxide Gas

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