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

    EPIVIEW

    K Number: K961319 · Decision Jul 8, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    79
    Applicant Total
    81
    Review Days
    94

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    Basic Information

    Device Name
    EPIVIEW
    K Number
    K961319
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Convatec, A Division of E.R. Squibb & Sons
    Date Received
    April 5, 1996
    Decision Date
    July 8, 1996
    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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