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510(k) Data Aggregation

    K Number
    K240722
    Device Name
    Derma-R Cream (Derma-R Cream)
    Manufacturer
    Raya Pharmaceuticals LLC
    Date Cleared
    2024-09-20

    (186 days)

    Product Code
    FRO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Raya Pharmaceuticals LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    It is intended for management of pruritus and Dryness of skin in Allergic contact dermatitis. Not to be used on Breached or Compromised skin or open sores.
    Device Description
    Derma-R Cream is a non-sterile formulation intended for topical application. It is intended for management of pruritus and Dryness of skin in Atopic dermatitis and Allergic contact dermatitis. Not to be used on Breached or Compromised skin or open sores.
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