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

    SAFE-T-SHIELD MOUTHPIECE

    K Number: K865093 · Decision Jan 15, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    162
    Registration Numbers
    162
    Same Product Code
    24
    Applicant Total
    9
    Review Days
    16

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    Basic Information

    Device Name
    SAFE-T-SHIELD MOUTHPIECE
    K Number
    K865093
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5620
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Medi Nuclear Corp., Inc.
    Date Received
    December 30, 1986
    Decision Date
    January 15, 1987
    Product Code
    BYP
    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
    BYP Mouthpiece, Breathing

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