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

    NU-DERM HYDROCOLLOID DRESSING

    K Number: K890545 · Decision Mar 23, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    4
    Review Days
    48

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    Basic Information

    Device Name
    NU-DERM HYDROCOLLOID DRESSING
    K Number
    K890545
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Johnson & Johnson Patient Care, Inc.
    Date Received
    February 3, 1989
    Decision Date
    March 23, 1989
    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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