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

    LE VEEN WOUND SPLINT

    K Number: K863570 · Decision Sep 29, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    19
    Applicant Total
    1
    Review Days
    17

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    Basic Information

    Device Name
    LE VEEN WOUND SPLINT
    K Number
    K863570
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4930
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Tek-Aid, Inc.
    Date Received
    September 12, 1986
    Decision Date
    September 29, 1986
    Product Code
    KGS
    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
    KGS Retention Device, Suture

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