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

    WATER JEL STERILE GEL-SOAKED BURN DRESSING

    K Number: K885321 · Decision Mar 22, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    6
    Review Days
    84

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    Basic Information

    Device Name
    WATER JEL STERILE GEL-SOAKED BURN DRESSING
    K Number
    K885321
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Pfizer Pharmaceuticals
    Date Received
    December 28, 1988
    Decision Date
    March 22, 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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