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

    ENHANCE CLITORAL STIMULATION AID

    K Number: K043480 · Decision Jun 8, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    174

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    Basic Information

    Device Name
    ENHANCE CLITORAL STIMULATION AID
    K Number
    K043480
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5970
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Gynavations, Inc.
    Date Received
    December 16, 2004
    Decision Date
    June 8, 2005
    Product Code
    NBV
    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
    NBV Device, Engorgement, Clitoral

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