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

    INFLATABLE FULL ARM SPLINT

    K Number: K874053 · Decision Nov 23, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    6
    Applicant Total
    5
    Review Days
    49

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    Basic Information

    Device Name
    INFLATABLE FULL ARM SPLINT
    K Number
    K874053
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.3900
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Vinyl Technology, Inc.
    Date Received
    October 5, 1987
    Decision Date
    November 23, 1987
    Product Code
    FZF
    Advisory Committee
    General, Plastic Surgery
    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
    FZF Splint, Extremity, Inflatable, External

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    Other Clearances by Vinyl Technology, Inc.

    K Number Device Name
    K874774 TROUSERS, PNEUMATIC, ANTI-SHOCK THREE BLADDERS
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