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

    4MM & 5MM FILE

    K Number: K841981 · Decision Jun 19, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    81
    Registration Numbers
    81
    Same Product Code
    4
    Applicant Total
    19
    Review Days
    36

    Basic Information

    Device Name
    4MM & 5MM FILE
    K Number
    K841981
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.4540
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    STAINLESS MFG., INC.
    Date Received
    May 14, 1984
    Decision Date
    June 19, 1984
    Product Code
    HTP
    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
    HTP File

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