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

    BURNAID BURN FIRST AID DRESSING

    K Number: K953505 · Decision Feb 9, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    144
    Applicant Total
    1
    Review Days
    198

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    Basic Information

    Device Name
    BURNAID BURN FIRST AID DRESSING
    K Number
    K953505
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Rye Pharmaceuticals Pty. , Ltd.
    Date Received
    July 26, 1995
    Decision Date
    February 9, 1996
    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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