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

    BVN

    K Number: K800695 · Decision May 2, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    239
    Registration Numbers
    239
    Same Product Code
    36
    Applicant Total
    1
    Review Days
    35

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    Basic Information

    Device Name
    BVN
    K Number
    K800695
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3025
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Donald J. Mangus, M.D.
    Date Received
    March 28, 1980
    Decision Date
    May 2, 1980
    Product Code
    ITG
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ITG Bandage, Cast

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