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

    SUTURE TENSION ADJUSTMENT REEL

    K Number: K904136 · Decision Oct 2, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    19
    Applicant Total
    2
    Review Days
    26

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    Basic Information

    Device Name
    SUTURE TENSION ADJUSTMENT REEL
    K Number
    K904136
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4930
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Surgical Systems, Inc.
    Date Received
    September 6, 1990
    Decision Date
    October 2, 1990
    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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