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

    JAMES LECKEY PRONE STANDER

    K Number: K944307 · Decision Dec 22, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    34
    Applicant Total
    2
    Review Days
    111

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    Basic Information

    Device Name
    JAMES LECKEY PRONE STANDER
    K Number
    K944307
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3750
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    James Leckey Design
    Date Received
    September 2, 1994
    Decision Date
    December 22, 1994
    Product Code
    INW
    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
    INW Table, Mechanical

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