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

    NEAL WRIST CONES

    K Number: K925924 · Decision Apr 8, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    109
    Registration Numbers
    109
    Same Product Code
    133
    Applicant Total
    2
    Review Days
    136

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    Basic Information

    Device Name
    NEAL WRIST CONES
    K Number
    K925924
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6760
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neal & Assoc., Inc.
    Date Received
    November 23, 1992
    Decision Date
    April 8, 1993
    Product Code
    FMQ
    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
    FMQ Restraint, Protective

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