BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

    LUNAPADS

    K Number: K010986 · Decision Jun 13, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    81
    Registration Numbers
    81
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    72

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    Basic Information

    Device Name
    LUNAPADS
    K Number
    K010986
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    884.5435
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Lunapads International Products, Ltd.
    Date Received
    April 2, 2001
    Decision Date
    June 13, 2001
    Product Code
    NUQ
    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
    NUQ Pad, Menstrual, Reusable