BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    Harmony Latex Dam, Harmony Non-Latex Dam

    K Number: K203727 · Decision Aug 5, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    227

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    Basic Information

    Device Name
    Harmony Latex Dam, Harmony Non-Latex Dam
    K Number
    K203727
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pamco Distributing, Inc.
    Date Received
    December 21, 2020
    Decision Date
    August 5, 2021
    Product Code
    MSC
    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
    MSC Barrier, Std, Oral Sex

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