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

    CASTLE #3241 GAS AERATOR

    K Number: K813201 · Decision Dec 31, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    7
    Applicant Total
    37
    Review Days
    48

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    Basic Information

    Device Name
    CASTLE #3241 GAS AERATOR
    K Number
    K813201
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6100
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Sybron Corp.
    Date Received
    November 13, 1981
    Decision Date
    December 31, 1981
    Product Code
    FLI
    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
    FLI Cabinet, Ethylene-Oxide Gas Aerator

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