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

    DISPOSABLE OPTICAL VALVULOTOME

    K Number: K914457 · Decision Feb 5, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    26
    Applicant Total
    5
    Review Days
    121

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    Basic Information

    Device Name
    DISPOSABLE OPTICAL VALVULOTOME
    K Number
    K914457
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4885
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Nobles-Lai Engineering, Inc.
    Date Received
    October 7, 1991
    Decision Date
    February 5, 1992
    Product Code
    MGZ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MGZ Valvulotome

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