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    K Number
    K023717
    Device Name
    SPERM WASH MEDIUM WITH GENTAMICIN
    Manufacturer
    CONCEPTION TECHNOLOGIES
    Date Cleared
    2002-12-13

    (38 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SPERM WASH MEDIUM WITH GENTAMICIN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Sperm Wash Medium is used for in vitro washing for IUI procedures, incubation and manipulation.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter from the FDA for "Sperm Wash Medium & Sperm Wash Medium with Gentamicin". It does not contain information about acceptance criteria or a study proving device performance in the way requested for AI/medical device performance.

    Therefore, I cannot provide the details about acceptance criteria or a study from the provided text. The letter primarily states the device's substantial equivalence to a predicate device and outlines regulatory requirements.

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