BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MOONCUP, STYLE A & B

    K Number: K040335 · Decision Mar 30, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    79
    Registration Numbers
    79
    Same Product Code
    15
    Applicant Total
    1
    Review Days
    413

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    Basic Information

    Device Name
    MOONCUP, STYLE A & B
    K Number
    K040335
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5400
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mooncup, LLC
    Date Received
    February 11, 2004
    Decision Date
    March 30, 2005
    Product Code
    HHE
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HHE Cup, Menstrual

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