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

    THE (CROM) TESTER

    K Number: K870767 · Decision Mar 17, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    12
    Applicant Total
    6
    Review Days
    19

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    Basic Information

    Device Name
    THE (CROM) TESTER
    K Number
    K870767
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.1520
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Twin City Surgical, Inc.
    Date Received
    February 26, 1987
    Decision Date
    March 17, 1987
    Product Code
    KQW
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KQW Goniometer, Nonpowered

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