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

    TC SYSTEM-COVER

    K Number: K890867 · Decision Mar 14, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    99
    Registration Numbers
    99
    Same Product Code
    25
    Applicant Total
    2
    Review Days
    21

    Basic Information

    Device Name
    TC SYSTEM-COVER
    K Number
    K890867
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4580
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    TRANSMEDICAL CORP.
    Date Received
    February 21, 1989
    Decision Date
    March 14, 1989
    Product Code
    FTA
    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
    FTA Light, Surgical, Accessories

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