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510(k) Data Aggregation

    K Number
    K993361
    Device Name
    TUBING EXTENSION SET
    Manufacturer
    HURRICANE MEDICAL
    Date Cleared
    2000-01-04

    (90 days)

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

    HURRICANE MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is used by an ophthalmic surgeon to extend the irrigation/aspiration syringe by use of the tubing extension set away from the cannula allowing better control of irrigation/aspiration during the ophthalmic surgical procedure. This also allows the surgeons assistant to perform the irrigation/aspiration process if needed.
    Device Description
    The Hurricane Medical tubing extension set consists of a length of silicone tubing with huer taper hubs (one male and one female) attached to both ends.
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    K Number
    K990672
    Device Name
    LACRIMAL INTUBATION SET, DACRYOCYSTORHINOSTOMY (DCR) SET
    Manufacturer
    HURRICANE MEDICAL
    Date Cleared
    1999-05-18

    (77 days)

    Product Code
    OKS
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    HURRICANE MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    These devices are used in ophthalmic surgery to reconstruct the lacrimal outflow system, dacryocystorhinostomy, and other lacrimal system reconstruction.
    Device Description
    The referenced devices consist of two pieces of the same gauge size and leagues statules. Description: The reterenced devices consist of two pieces of the same from the relations two by frietion fft, gluing, or crimping.
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    K Number
    K990671
    Device Name
    DRAINAGE WICK; SURGICAL SPEARS AND SPONGES, CORNEAL LIGHT SHIELD, INSTRUMENT WIPE
    Manufacturer
    HURRICANE MEDICAL
    Date Cleared
    1999-05-10

    (69 days)

    Product Code
    HOZ
    Regulation Number
    886.4790
    Why did this record match?
    Applicant Name (Manufacturer) :

    HURRICANE MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    These devices are used to remove excess fluid and debris from the surgical area or instrument. Also, placed on the cornea to moisten the cornea and protect the retina from the intense operating light during ophthalmic surgery.
    Device Description
    Hurricane Medical corneal light shields are manufactured from non-linting hydrophilic polyvinyl alcohol sponge with a pore size of approximately 100 micron. Hurricane Medical wipes are made from medical grade nonlinting hydrophilic polyvinyl alcohol (PVA) sponge. Hurricane Medical Eye Sponges and Spears are highly absorbent materials designed for absorption of fluids during eye surgery. Absorbent materials will include hydrocellulose, polyvinyl alcohol, viscose and US-origin cotton. Hurricane Medical fluid wicks are made from non-linting polyvinyl alcohol (PVA) sponge with a pore size of approximately 100 microns.
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