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

    FRONT-LINE Field Sterilizer (FL135)

    K Number: K243801 · Decision Mar 7, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    183
    Applicant Total
    2
    Review Days
    86

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    Basic Information

    Device Name
    FRONT-LINE Field Sterilizer (FL135)
    K Number
    K243801
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.6880
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fort Defiance Industries, LLC
    Date Received
    December 11, 2024
    Decision Date
    March 7, 2025
    Product Code
    FLE
    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
    FLE Sterilizer, Steam

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    Other Clearances by Fort Defiance Industries, LLC

    K Number Device Name
    K213457 Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135