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510(k) Data Aggregation

    K Number
    K092398
    Device Name
    HSV STRAW
    Manufacturer
    CRYO BIO SYSTEM
    Date Cleared
    2010-10-06

    (426 days)

    Product Code
    MQK, MOK
    Regulation Number
    884.6160
    Why did this record match?
    Applicant Name (Manufacturer) :

    CRYO BIO SYSTEM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HSV Straw is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 Cell and blastocyst stage embryos.
    Device Description
    An embryo is vitrified using the HSV Straw by placing an embryo suspended in a 0.5ul All entrification solution solution in a curved polymeric spatula (Medical Grade. Styrene-Butadiene Copolymer). The curved spatula is inserted in an outer straw with a Styrene-Butadiene Coporymer). The open, proximal end of the straw is sealed by the user. The sealed, weighted unsal Chd. The open, promishar effect freezing-vitrification. The weighted straw seated straw is placed in liquid nitrogen for embryo storage. Thawing-rewarming: While the remains in liquid nitrogen, part of the outer tube is cut away. The curved spatial, distal tip tellians in inquir mirogen, part of the outer straw and immediately immersed in thawing solution where thawing and dilution of the remaining vitrification solution occur simultaneously.
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    K Number
    K002595
    Device Name
    CBS STRAW
    Manufacturer
    CRYO BIO SYSTEM
    Date Cleared
    2000-11-17

    (88 days)

    Product Code
    MQG
    Regulation Number
    884.6120
    Why did this record match?
    Applicant Name (Manufacturer) :

    CRYO BIO SYSTEM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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