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

    EYE ARTIFICIAL CUSTOM

    K Number: K904962 · Decision Aug 30, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    5
    Applicant Total
    2
    Review Days
    298

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    EYE ARTIFICIAL CUSTOM
    K Number
    K904962
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.3200
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Midwest Eye Laboratories, Inc.
    Date Received
    November 5, 1990
    Decision Date
    August 30, 1991
    Product Code
    HQH
    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
    HQH Eye, Artificial, Non-Custom

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (HQH), ordered by most recent decision date.

    ROBERT B. SCOTT PLASTIC ARTIFICAL

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    CUSTOM ARTIFICIAL HUMAN EYES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    CUSTOM OCULAR PROSTHESIS

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    THE NISSEL ARTIFICIAL EYE

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    SCLERAL POWDER

    FDA 510(k)
    FDA Class 1 ·Ophthalmic
    View all

    Other Clearances by Midwest Eye Laboratories, Inc.

    K Number Device Name
    K904961 ARTIFICIAL SCLERAL SHELL