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

    PEDIATRIC POSITION HOLDER

    K Number: K810609 · Decision Mar 20, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    13
    Applicant Total
    12
    Review Days
    14

    Basic Information

    Device Name
    PEDIATRIC POSITION HOLDER
    K Number
    K810609
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5680
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    KAYE PRODUCTS, INC.
    Date Received
    March 6, 1981
    Decision Date
    March 20, 1981
    Product Code
    FRP
    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
    FRP Holder, Infant Position

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