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

    FLEXGUIDE

    K Number: K940799 · Decision Aug 18, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    133
    Registration Numbers
    133
    Same Product Code
    31
    Applicant Total
    11
    Review Days
    177

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    Basic Information

    Device Name
    FLEXGUIDE
    K Number
    K940799
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5790
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Scientific Sales Intl., Inc.
    Date Received
    February 22, 1994
    Decision Date
    August 18, 1994
    Product Code
    BSR
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BSR Stylet, Tracheal Tube

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