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

    SILASTIC TENDON PASSER H.P.

    K Number: K811679 · Decision Jul 10, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    8
    Applicant Total
    31
    Review Days
    25

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    Basic Information

    Device Name
    SILASTIC TENDON PASSER H.P.
    K Number
    K811679
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.4540
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Dow Corning Corp. Healthcare Industries Materials
    Date Received
    June 15, 1981
    Decision Date
    July 10, 1981
    Product Code
    HWQ
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HWQ Passer

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