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

    WATER JEL STERILE GEL-SOAKED BURN DRESSING

    K Number: K900516 · Decision Mar 19, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    1
    Review Days
    45

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    Basic Information

    Device Name
    WATER JEL STERILE GEL-SOAKED BURN DRESSING
    K Number
    K900516
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Trilling Medical Technologies, Inc.
    Date Received
    February 2, 1990
    Decision Date
    March 19, 1990
    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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