BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ROSEALAE

    K Number: K782001 · Decision Dec 7, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    573
    Registration Numbers
    573
    Same Product Code
    64
    Applicant Total
    1
    Review Days
    3

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    Basic Information

    Device Name
    ROSEALAE
    K Number
    K782001
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6060
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Asmb
    Date Received
    December 4, 1978
    Decision Date
    December 7, 1978
    Product Code
    KME
    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
    KME Bedding, Disposable, Medical

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