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

    MULES SPHERE GLASS (SEVERAL SIZES)

    K Number: K895908 · Decision Jan 8, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    38
    Applicant Total
    1
    Review Days
    90

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    Basic Information

    Device Name
    MULES SPHERE GLASS (SEVERAL SIZES)
    K Number
    K895908
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.3320
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Ginsberg Scientific, Inc.
    Date Received
    October 10, 1989
    Decision Date
    January 8, 1990
    Product Code
    HPZ
    Advisory Committee
    Ophthalmic
    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
    HPZ Implant, Eye Sphere

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