BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SILASTIC HAMMERTOE IMPLANT (SWANSON-WELL

    K Number: K801094 · Decision Jun 9, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    20
    Applicant Total
    31
    Review Days
    32

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    Basic Information

    Device Name
    SILASTIC HAMMERTOE IMPLANT (SWANSON-WELL
    K Number
    K801094
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3720
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Dow Corning Corp. Healthcare Industries Materials
    Date Received
    May 8, 1980
    Decision Date
    June 9, 1980
    Product Code
    KWH
    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
    KWH Prosthesis, Toe, Constrained, Polymer

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