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510(k) Data Aggregation

    K Number
    K030117
    Device Name
    ENHANCE SPERM FREEZE
    Manufacturer
    CONCEPTION TECHNOLOGY, INC.
    Date Cleared
    2003-03-20

    (66 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONCEPTION TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sperm Freeze is intended to be used as a cryopreservation medium for human sperm.
    Device Description
    Not Found
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    K Number
    K030116
    Device Name
    ENHANCE-S PLUS H
    Manufacturer
    CONCEPTION TECHNOLOGY, INC.
    Date Cleared
    2003-02-12

    (30 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONCEPTION TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cell isolation media used for separation and purification of human sperm for assisted reproduction procedures.
    Device Description
    Not Found
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    K Number
    K991322
    Device Name
    ENHANCE-S PLUS
    Manufacturer
    CONCEPTION TECHNOLOGY, INC.
    Date Cleared
    1999-07-26

    (98 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONCEPTION TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cell isolation media used for separation and purification of human sperm for assisted reproduction procedures.
    Device Description
    Not Found
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    K Number
    K991104
    Device Name
    MICROTOOLS
    Manufacturer
    CONCEPTION TECHNOLOGY, INC.
    Date Cleared
    1999-07-19

    (109 days)

    Product Code
    MQH
    Regulation Number
    884.6130
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONCEPTION TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Conceptions Technologies' Microtools are used in the laboratory as a microtool to denude, micromanipulate, inject, hold or transfer human gametes or embryos for assisted hatching, ICSI, or other assisted reproduction procedures.
    Device Description
    Microtools
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    K Number
    K973860
    Device Name
    OVULON MONITOR
    Manufacturer
    CONCEPTION TECHNOLOGY, INC.
    Date Cleared
    1998-01-07

    (90 days)

    Product Code
    NGE
    Regulation Number
    862.1485
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONCEPTION TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ovulon Monitor is a fertility aid intended for over-the-counter purchase. It is an electronic biosensor designed for home use that vields digital information (data points) relative to electron flow in the extracellular milieu of the posterior fornix and paracervical region of the vagina. The Ovulon Monitor is intended for daily use in normally cycling (i.e., regularly menstruating and, presumably, ovulating) healthy females who may desire to achieve pregnancy (conception). Much as a basal body temperature thermometer or a home urine LH kit, the Ovulon Monitor serves as an independent information aid to the woman by helping to define the fertile window near the midpoint of each monthly cycle, whereby she may choose the proper timing for vaginal intercourse. If the user chooses the guidance of a physician for fertility treatment, the Ovulon Monitor may serve to provide the user and her physician with data to better time artificial insemination or other interventional techniques. The Ovulon Monitor is to be used as an aid to conception and is not to be used for contraception. After six (6) or more cycles, if the user is not successful in achieving conception, she should consult her physician.
    Device Description
    The Ovulon Monitor is an electronic biosensor designed for home use that vields digital information (data points) relative to electron flow in the extracellular milieu of the posterior fornix and paracervical region of the vagina.
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