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

    PAREL RARE EARTH MAGNET, I.O.M., INTRAOCULAR MAG

    K Number: K880855 · Decision Apr 1, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    4
    Applicant Total
    2
    Review Days
    31

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    Basic Information

    Device Name
    PAREL RARE EARTH MAGNET, I.O.M., INTRAOCULAR MAG
    K Number
    K880855
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4445
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Richard James, Inc.
    Date Received
    March 1, 1988
    Decision Date
    April 1, 1988
    Product Code
    HPN
    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
    HPN Magnet, Permanent

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