BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇬🇧 United Kingdom

    RAPIDEX BIOLOGICAL SURFACTANT

    K Number: K862282 · Decision May 11, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    150
    Registration Numbers
    150
    Same Product Code
    18
    Applicant Total
    1
    Review Days
    329

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    Basic Information

    Device Name
    RAPIDEX BIOLOGICAL SURFACTANT
    K Number
    K862282
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6150
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Rapidex of London
    Date Received
    June 16, 1986
    Decision Date
    May 11, 1987
    Product Code
    FLG
    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
    FLG Cleaner, Ultrasonic, Medical Instrument

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