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

    BIOCLUSIVE(R) ABSORBENT DRESSING

    K Number: K896828 · Decision Nov 21, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    21
    Applicant Total
    10
    Review Days
    352

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    Basic Information

    Device Name
    BIOCLUSIVE(R) ABSORBENT DRESSING
    K Number
    K896828
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4018
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Johnson & Johnson International
    Date Received
    December 4, 1989
    Decision Date
    November 21, 1990
    Product Code
    KOZ
    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
    KOZ Beads, Hydrophilic, For Wound Exudate Absorption

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