BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent for Some Indications 🇩🇪 Germany

    PROCEL BURN COVER/PROCEL BURN TREATMENT COVER

    K Number: K943280 · Decision Aug 18, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    79
    Applicant Total
    1
    Review Days
    42

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    Basic Information

    Device Name
    PROCEL BURN COVER/PROCEL BURN TREATMENT COVER
    K Number
    K943280
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    W.L. Gore & Company, GmbH
    Date Received
    July 7, 1994
    Decision Date
    August 18, 1994
    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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