LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K092985
    Device Name
    BELLECUP
    Manufacturer
    LIBRETTE, INC
    Date Cleared
    2010-06-28

    (273 days)

    Product Code
    HHE
    Regulation Number
    884.5400
    Why did this record match?
    Applicant Name (Manufacturer) :

    LIBRETTE, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BelleCup is a receptacle placed in the vagina to collect blood and cellular debris that is extruded from the uterus via the cervix during menstruation.
    Device Description
    Trade Name: BelleCup Common Name: Menstrual Cup Device Class: II Review Panel: Obstetrics/Gynecology Product Code: HHE Regulation Number: 21 CFR 884.5400 The device is manufactured from a single component, LIM6040-D2 silicone elastomer, which is compliant with 21 CFR 177.2600 (Rubber articles intended for repeated use). The BelleCup is not supplied sterile.
    Ask a Question

    Page 1 of 1