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

    POLYSKIN(R) M.R. MOIST RESPONSIVE TRANSPARENT DRESSING

    K Number: K942774 · Decision Jul 20, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    79
    Applicant Total
    63
    Review Days
    37

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    Basic Information

    Device Name
    POLYSKIN(R) M.R. MOIST RESPONSIVE TRANSPARENT DRESSING
    K Number
    K942774
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    The Kendal Co.
    Date Received
    June 13, 1994
    Decision Date
    July 20, 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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