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510(k) Data Aggregation

    K Number
    K133295
    Device Name
    QUALIS
    Manufacturer
    MENICON CO., LTD. NEW BUSINESS DIVISION
    Date Cleared
    2014-06-18

    (236 days)

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

    MENICON CO., LTD. NEW BUSINESS DIVISION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Qualis is intended for preparing motile human sperm for use in the treatment of infertile couples by intracytoplasmic sperm insertion (ICSI) fertilization.
    Device Description
    The Qualis is a sterile, disposable, plastic laboratory dish that contains four chambers connected through micro-channels and is designed to be used in conjunction with commercially available culture medium to selectively separate motile spermatozoa (sperm) for non-motile spermatozoa and cellular debris.
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