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    K Number
    K072381
    Device Name
    SOFTPAP CERVICAL CELL COLLECTOR
    Manufacturer
    CYTOCORE, INC.
    Date Cleared
    2008-01-30

    (159 days)

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

    CYTOCORE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the collection of cervical cytology specimens for Pap test analysis. The SoftPAP™ Cervical Sample Collector should not be used after the first 10 weeks of gestation in pregnant patients.
    Device Description
    The CytoCore, Inc. SoftPAP™ Collector is a multicomponent assembly for the collection of exfoliated cervical epithelial cells. Its major components are a disposable Balloon assembly (Balloon and rod), and a reusable Handle. The Balloon provides the conformal surface upon which the cells are collected. The Handle provides a means of manipulating and expanding the Balloon during the sampling process. The Balloon inflates against the cervix and conformally contacts the entire areas to be sampled, namely the ectocervical, the transformation zone, and the endocervical surfaces.
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