BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    2018 ARTERIAL/VENOUS PRESSURE DRESSING

    K Number: K895845 · Decision Nov 1, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    502
    Registration Numbers
    502
    Same Product Code
    106
    Applicant Total
    32
    Review Days
    29

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    Basic Information

    Device Name
    2018 ARTERIAL/VENOUS PRESSURE DRESSING
    K Number
    K895845
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4020
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Advance Medical Designs, Inc.
    Date Received
    October 3, 1989
    Decision Date
    November 1, 1989
    Product Code
    NAD
    Advisory Committee
    General, Plastic Surgery
    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
    NAD Dressing, Wound, Occlusive

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