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

    MBI ILLUMINATED RETINAL PICK

    K Number: K964405 · Decision May 13, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    39
    Applicant Total
    3
    Review Days
    190

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    Basic Information

    Device Name
    MBI ILLUMINATED RETINAL PICK
    K Number
    K964405
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    M.B. Industries, Inc.
    Date Received
    November 4, 1996
    Decision Date
    May 13, 1997
    Product Code
    MPA
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MPA Endoilluminator

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    Other Clearances by M.B. Industries, Inc.

    K Number Device Name
    K964553 MBI CO-AXIAL ILLUMINATED RETINAL PICK
    K961036 MBI FIBEROPTIC ENDO-ILLUMINATOR