BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇬 Singapore

    Twoplus Applicator

    K Number: K232579 · Decision Dec 21, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    118

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    Basic Information

    Device Name
    Twoplus Applicator
    K Number
    K232579
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.6110
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Hannah Life Technologies Pte , Ltd.
    Date Received
    August 25, 2023
    Decision Date
    December 21, 2023
    Product Code
    QYZ
    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
    QYZ At Home Intravaginal Insemination System

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