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

    MOLNLYCKE ETE STERILE NON-ADHERENT DRESS

    K Number: K830166 · Decision Feb 9, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    402
    Registration Numbers
    403
    Same Product Code
    861
    Applicant Total
    7
    Review Days
    22

    Basic Information

    Device Name
    MOLNLYCKE ETE STERILE NON-ADHERENT DRESS
    K Number
    K830166
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    LADA INTL., INC.
    Date Received
    January 18, 1983
    Decision Date
    February 9, 1983
    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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