BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇨🇳 China

    Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)

    K Number: K240097 · Decision May 22, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    113
    Registration Numbers
    113
    Same Product Code
    126
    Applicant Total
    2
    Review Days
    131

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    Basic Information

    Device Name
    Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)
    K Number
    K240097
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ushare Medical, Inc.
    Date Received
    January 12, 2024
    Decision Date
    May 22, 2024
    Product Code
    QSY
    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
    QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics

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