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

    ELASTO-GEL OCCLUSIVE DRESSING

    K Number: K872165 · Decision Jun 26, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    402
    Registration Numbers
    403
    Same Product Code
    861
    Applicant Total
    5
    Review Days
    21

    Basic Information

    Device Name
    ELASTO-GEL OCCLUSIVE DRESSING
    K Number
    K872165
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    SOUTHWEST TECHNOLOGIES, INC.
    Date Received
    June 5, 1987
    Decision Date
    June 26, 1987
    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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    Other Clearances by SOUTHWEST TECHNOLOGIES, INC.

    K Number Device Name
    K102478 OTC ELASTO-GEL MANUKA HONEY WOUND DRESSING
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