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

    PROLONGED OCCLUSION DRESSING I

    K Number: K920875 · Decision Jun 16, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    402
    Registration Numbers
    403
    Same Product Code
    861
    Applicant Total
    2
    Review Days
    111

    Basic Information

    Device Name
    PROLONGED OCCLUSION DRESSING I
    K Number
    K920875
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    FERNDAL LABORATORIES
    Date Received
    February 26, 1992
    Decision Date
    June 16, 1992
    Product Code
    FRO
    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
    FRO Dressing, Wound, Drug

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    Other Clearances by FERNDAL LABORATORIES

    K Number Device Name
    K920874 PROLONGED OCCLUSION DRESSING II