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

    VARIOUSLY SIZED STERILE COTTON WOUND DRESSINGS

    K Number: K891133 · Decision May 24, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    2
    Review Days
    82

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    Basic Information

    Device Name
    VARIOUSLY SIZED STERILE COTTON WOUND DRESSINGS
    K Number
    K891133
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Elwyn, Inc.
    Date Received
    March 3, 1989
    Decision Date
    May 24, 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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