BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇬🇧 United Kingdom

    SINCLAIR WOUND AND SKIN EMULSION

    K Number: K024367 · Decision Jul 28, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    144
    Applicant Total
    8
    Review Days
    209

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    Basic Information

    Device Name
    SINCLAIR WOUND AND SKIN EMULSION
    K Number
    K024367
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sinclair Pharmaceuticals, Ltd.
    Date Received
    December 31, 2002
    Decision Date
    July 28, 2003
    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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