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

    BURN-AID HYDROGEL,BURN DRESSING,BURN BLANKET

    K Number: K961067 · Decision May 16, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    144
    Applicant Total
    2
    Review Days
    59

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    Basic Information

    Device Name
    BURN-AID HYDROGEL,BURN DRESSING,BURN BLANKET
    K Number
    K961067
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtrak Intl., Inc.
    Date Received
    March 18, 1996
    Decision Date
    May 16, 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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