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

    BITE BLOCK

    K Number: K896691 · Decision Feb 12, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    76

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    Basic Information

    Device Name
    BITE BLOCK
    K Number
    K896691
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Endoscopix
    Date Received
    November 28, 1989
    Decision Date
    February 12, 1990
    Product Code
    MNK
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MNK Endoscopic Bite Block

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