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

    OXY-BLOC

    K Number: K931044 · Decision Oct 4, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    124
    Registration Numbers
    124
    Same Product Code
    5
    Applicant Total
    7
    Review Days
    217

    Basic Information

    Device Name
    OXY-BLOC
    K Number
    K931044
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    GI SUPPLY
    Date Received
    March 1, 1993
    Decision Date
    October 4, 1993
    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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