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

    REDI-RELEASE ABSORBENT DRESSING

    K Number: K904604 · Decision Jan 7, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    21
    Applicant Total
    2
    Review Days
    89

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    Basic Information

    Device Name
    REDI-RELEASE ABSORBENT DRESSING
    K Number
    K904604
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4018
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Fountain Pharmaceuticals, Inc.
    Date Received
    October 10, 1990
    Decision Date
    January 7, 1991
    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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