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510(k) Data Aggregation

    K Number
    K990292
    Device Name
    I/A (IRRIGATION/ASPIRATION) PACK, POSTERIOR VITRECOMY PACK, ANTERIOR VIRECTOMY PACK, PHACOEMULSIFICATION PACK, ADMIINISN
    Manufacturer
    OPHTHALMIC CONSULTANTS, INC.
    Date Cleared
    1999-11-19

    (294 days)

    Product Code
    HQE
    Regulation Number
    886.4150
    Why did this record match?
    Applicant Name (Manufacturer) :

    OPHTHALMIC CONSULTANTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To provide single-use components to be used in conjunction with a facility's existing compatable equipment, in one convenient kit/pack, for ophthalmic surgical procedures, used in accordance with the equipment manufacturer's instructions, performed by a certified clinician in a clinical setting, as follows: - (1) Phaco Emulsifier Pack: Provides the irrigation and aspiration tubing/ administration sets and equipment covers/drapes used in anterior, e.g., cataract, surgical procedures; - (2) Anterior Vitrectomy Pack: Provides the vitrector, surgical blade, scleral plugs for incision patency, and 10 cc syringe and fluid irrigation and aspiration tubing/administration sets, and equipment covers/drapes, used in anterior surgical procedures; - (3) Anterior Collection Cassette: Provides the fluid collection cassette and tubing for the collection and disposal of fluids during ophthalmic anterior surgical procedures: - (4) Posterior Vitrectomy Pack: Provides the vitrector, surgical blade, scleral plugs for incision patency, and 10 cc syringe and fluid irrigation and aspiration tubing/administration sets, and equipment covers/drapes, used in posterior segment, e.g., retinal, surgical procedures; - (5) Posterior Collection Cassette: Provides the fluid collection cassette and tubing for the collection and disposal of fluids during ophthalmic posterior surgical procedures. - (6) Filtered Irrigation Administration Set: Provides commonly used tubing sets for the filtering and administration of fluids for flushing/irrigating a surgical site during either posterior or anterior ophthalmic procedures.
    Device Description
    Ophthalmic surgical kits/packs containing components used for irrigation/aspiration, anterior and posterior vitrectomies, phacoemulsification, and or administration of fluids.
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    K Number
    K990872
    Device Name
    SCLERAL PLUGS, 19 AND 20 GAUGE
    Manufacturer
    OPHTHALMIC CONSULTANTS, INC.
    Date Cleared
    1999-07-13

    (119 days)

    Product Code
    LXP
    Regulation Number
    886.4155
    Why did this record match?
    Applicant Name (Manufacturer) :

    OPHTHALMIC CONSULTANTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The scleral plugs are provided as part of single- and multiple-use surgical component kits/packs, or as kit replacements, in order to maintain patency of a previously made incision in the sclera of the eye, during ophthalmic surgical procedures, performed by a certified clinician in a clinical setting.
    Device Description
    Scleral plugs, 19 and 20 ga., for use in ophthalmic surgical procedures. Both as stainless steel, with the 19 ga. plugs gold plated, and the 20 ga. plugs silver plated.
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