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

    FLOWGEL(R) TOPICAL WOUND DRESSING

    K Number: K926353 · Decision Feb 22, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    60
    Registration Numbers
    60
    Same Product Code
    146
    Applicant Total
    1
    Review Days
    428

    Basic Information

    Device Name
    FLOWGEL(R) TOPICAL WOUND DRESSING
    K Number
    K926353
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    MEDIVENTURES, INC.
    Date Received
    December 21, 1992
    Decision Date
    February 22, 1994
    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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