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510(k) Data Aggregation

    K Number
    K192671
    Device Name
    Hemostatic Xerogel Sponge
    Manufacturer
    Solaplus Biotech Co., Ltd.
    Date Cleared
    2020-08-28

    (337 days)

    Product Code
    QSY, FRO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Solaplus Biotech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hemostatic Xerogel Sponge is a hemostatic dressing for the external, temporary control of severely bleeding wounds.
    Device Description
    The proposed device, Hemostatic xerogel sponge, is available in three models for different size. The Hemostatic Xerogel Sponge is a irradiation sterilized, single used device, and supplied in sterility maintenance package which could maintain the sterility of the device during the shelf life of 2 years.
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