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510(k) Data Aggregation

    K Number
    K060320
    Device Name
    FEMECC ENDOCERVICAL CURETTE
    Manufacturer
    FEMSPEC L.L.C.
    Date Cleared
    2006-07-28

    (170 days)

    Product Code
    PCF
    Regulation Number
    884.1050
    Why did this record match?
    Applicant Name (Manufacturer) :

    FEMSPEC L.L.C.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FemSpec, LLC, FemECC™ Endocervical Curette is a sterile, disposable curette indicated for single patient use in obtaining tissue samples from the endocervical canal for histological analysis.
    Device Description
    FemSpec, LLC, FemECC™ Endocervical Curette is a sterile, disposable curette.
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    K Number
    K052192
    Device Name
    FEMSPCE-S DISPOSABLE STERILE VAGINAL SPECULUM, MODEL ST-I
    Manufacturer
    FEMSPEC L.L.C.
    Date Cleared
    2006-02-02

    (175 days)

    Product Code
    HIB
    Regulation Number
    884.4530
    Why did this record match?
    Applicant Name (Manufacturer) :

    FEMSPEC L.L.C.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FemSpec, LLC, FemSpec-Sterile™ Disposable Sterile Vaginal Speculum is indicated for diagnostic procedures of the cervix.
    Device Description
    FemSpec, LLC, FemSpec-Sterile™ Disposable Sterile Vaginal Speculum
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    K Number
    K051294
    Device Name
    FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1
    Manufacturer
    FEMSPEC L.L.C.
    Date Cleared
    2005-12-21

    (217 days)

    Product Code
    HHK
    Regulation Number
    884.1175
    Why did this record match?
    Applicant Name (Manufacturer) :

    FEMSPEC L.L.C.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FemSpec, LLC, FemTest™ Endometrial Suction Curette is a sterile, disposable curette indicated for single patient use in obtaining tissue samples from the endocervical canal and for histological analysis of the uterine mucosal lining. It is indicated for: - Cancer screening - Endometrial dating - Determining response to estrogen replacement therapy - Bacterial culturing - Detection of pathology resulting in infertility - Monitoring patients receiving Tamoxifen therapy - Evaluating secondary amenorrhea
    Device Description
    FemSpec, LLC, FemTest™ Endometrial Suction Curette is a sterile, disposable curette.
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    K Number
    K041757
    Device Name
    FEMSPEC DISPOSABLE VAGINAL SPECULUM
    Manufacturer
    FEMSPEC L.L.C.
    Date Cleared
    2004-12-23

    (177 days)

    Product Code
    HIB
    Regulation Number
    884.4530
    Why did this record match?
    Applicant Name (Manufacturer) :

    FEMSPEC L.L.C.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FemSpec™ disposable vaginal speculum is indicated for diagnostic procedures of the cervix.
    Device Description
    The FemSpec disposable vaginal speculum consists of a soft plastic inflatable bladder, which once inserted into the vagina is inflated to uniformly press the vaginal wall open. Once inflated the bladder generates an annular space for diagnostic procedures of the cervix.
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