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510(k) Data Aggregation

    K Number
    K972034
    Device Name
    MEDPOR OCULAR CONFORMER
    Manufacturer
    POREX SURGICAL, INC.
    Date Cleared
    1998-01-20

    (232 days)

    Product Code
    HQN
    Regulation Number
    886.3130
    Why did this record match?
    Product Code :

    HQN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ophthalmic conformer is intended to be used as a post eye surgery device to prevent closure or adhesion during the healing process.
    Device Description
    An ophthalmic conformer is used after surgery on the eye to prevent closure or adhesion. It is a cup shaped device that is slipped between the orbit and the eye lid to cause separation. Its inner surface is formed to approximate the outer curvature of the eye. The ophthalmic conformer of this 510(k) is molded of Class VI. medical grade polymethyl methacrylate. It is sold in three sizes and it is sold non-sterile
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    K Number
    K970318
    Device Name
    OCULAR CONFORMER
    Manufacturer
    SOUTHWEST ARTIFICIAL EYES, INC.
    Date Cleared
    1997-07-07

    (160 days)

    Product Code
    HQN
    Regulation Number
    886.3130
    Why did this record match?
    Product Code :

    HQN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Conformer, is fabricated for the needs of a specific patient. Each is uniquely designed, fabricated, and fitted past-enucleation surgery, to maintain correct eye lid/socket configuration. In the other cases, to correct deformities of the eyelids, and/or socket. They are also fitted in a necessarily, sequential, increasing size, for infants afflicted with anophthalmia, or micro-ophthalmia, or in infants previous to the trauma or other socket and eyelid anomalies. Proper expansion therapy, with the use of sequential, increasing size conformers, is essential in eyelid development in infants and children.
    Device Description
    Not Found
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    K Number
    K970319
    Device Name
    OCULAR CONFORMER
    Manufacturer
    XAVIER A. GUERRA, OCULARIST, INC.
    Date Cleared
    1997-07-07

    (160 days)

    Product Code
    HQN
    Regulation Number
    886.3130
    Why did this record match?
    Product Code :

    HQN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Conformer, is fabricated for the needs of a The Custom specific patient. Each is uniquely designed, fabricated, and t fitted post-enucleation/evisceration surgery, to maintain correct eye lid/socket configuration. In the other cases, to correct deformities of the eyelids, and/or socket. They are also fitted in a necessarily, sequential, increasing size, for infants afflicted with anophthalmia, or micro-ophthalmia, as well as patients with trauma or other socket and eyelid anomalies. Proper expansion therapy, with the sential anomaries proper expansion chocariers, is essential in sequential, increasing Stac Controlmose), and eyelid development in infants and children.
    Device Description
    Not Found
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