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

    K51,K52 ENVIRONMENT ENCLOSURE

    K Number: K813207 · Decision Dec 31, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    80
    Applicant Total
    2
    Review Days
    43

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    Basic Information

    Device Name
    K51,K52 ENVIRONMENT ENCLOSURE
    K Number
    K813207
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4635
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Kohler
    Date Received
    November 18, 1981
    Decision Date
    December 31, 1981
    Product Code
    LEJ
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LEJ Booth, Sun Tan

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    Other Clearances by Kohler

    K Number Device Name
    K813208 K60 HABITAT ENVIRONMENT ENCLOSURE