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

    UNIVERSAL BITE BLOCK

    K Number: K960663 · Decision May 17, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    27
    Applicant Total
    23
    Review Days
    91

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    Basic Information

    Device Name
    UNIVERSAL BITE BLOCK
    K Number
    K960663
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5070
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    B&B Medical Technologies, Inc.
    Date Received
    February 16, 1996
    Decision Date
    May 17, 1996
    Product Code
    JXL
    Advisory Committee
    Neurology
    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
    JXL Block, Bite

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