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

    NIGHTFORM

    K Number: K041996 · Decision Aug 3, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    13
    Applicant Total
    1
    Review Days
    8

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    Basic Information

    Device Name
    NIGHTFORM
    K Number
    K041996
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5680
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Plastic Surgery Solutions, LLC
    Date Received
    July 26, 2004
    Decision Date
    August 3, 2004
    Product Code
    FRP
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    Y

    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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