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

    JOSLYN EO STERILIZER/ EO MODERNIZATION KIT

    K Number: K901146 · Decision Mar 7, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    25
    Applicant Total
    2
    Review Days
    360

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    Basic Information

    Device Name
    JOSLYN EO STERILIZER/ EO MODERNIZATION KIT
    K Number
    K901146
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Joslyn Valve Corp.
    Date Received
    March 12, 1990
    Decision Date
    March 7, 1991
    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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    Other Clearances by Joslyn Valve Corp.

    K Number Device Name
    K901147 JOSLYN STEAM STERILIZER / STEAM MODERNIZATION KIT