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

    PROCEL BURN COVER

    K Number: K915695 · Decision May 29, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    79
    Applicant Total
    163
    Review Days
    158

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    Basic Information

    Device Name
    PROCEL BURN COVER
    K Number
    K915695
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    W. L. Gore & Associates, Inc.
    Date Received
    December 23, 1991
    Decision Date
    May 29, 1992
    Product Code
    MGP
    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
    MGP Dressing, Wound And Burn, Occlusive

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