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

    NAIL SPLINT

    K Number: K850803 · Decision Oct 16, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    231

    Basic Information

    Device Name
    NAIL SPLINT
    K Number
    K850803
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    INRO MEDICAL DESIGNS, INC.
    Date Received
    February 27, 1985
    Decision Date
    October 16, 1985
    Product Code
    MQZ
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MQZ Prosthesis, Nail

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