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

    CASTLE MODEL 3146 GAS AERATOR

    K Number: K781484 · Decision Oct 27, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    7
    Applicant Total
    21
    Review Days
    60

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    Basic Information

    Device Name
    CASTLE MODEL 3146 GAS AERATOR
    K Number
    K781484
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6100
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Castle Co.
    Date Received
    August 28, 1978
    Decision Date
    October 27, 1978
    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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