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

    SUILE WOUND DRESSING

    K Number: K022967 · Decision Jul 8, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    2
    Review Days
    305

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    Basic Information

    Device Name
    SUILE WOUND DRESSING
    K Number
    K022967
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Hedonist Biochemical Technologies Co., Ltd.
    Date Received
    September 6, 2002
    Decision Date
    July 8, 2003
    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 Hedonist Biochemical Technologies Co., Ltd.

    K Number Device Name
    K041013 SUILE OINTMENT WOUND DRESSING