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

    SUTURE RETENTION DEVICE

    K Number: K883299 · Decision Aug 23, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    19
    Applicant Total
    2
    Review Days
    19

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    Basic Information

    Device Name
    SUTURE RETENTION DEVICE
    K Number
    K883299
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4930
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Edwards Orthopaedics Div., Baxter Healthcare Corp.
    Date Received
    August 4, 1988
    Decision Date
    August 23, 1988
    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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    Other Clearances by Edwards Orthopaedics Div., Baxter Healthcare Corp.

    K Number Device Name
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