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

    HylaGuard Moisturizing Cream

    K Number: K171879 · Decision Oct 16, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    144
    Applicant Total
    2
    Review Days
    115

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    Basic Information

    Device Name
    HylaGuard Moisturizing Cream
    K Number
    K171879
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Founders Science Group, LLC
    Date Received
    June 23, 2017
    Decision Date
    October 16, 2017
    Product Code
    MGQ
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

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    Other Clearances by Founders Science Group, LLC

    K Number Device Name
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