Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K112864
    Device Name
    SOFTSEAL-C
    Manufacturer
    Date Cleared
    2012-08-02

    (307 days)

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

    CHITOGEN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SoftSeal-C is indicated for use in the management of minor topical bleeding wounds such as minor abrasions and minor skin lacerations.
    Device Description
    SoftSeal-C pad is a sterile topical pad, packed in a foil pouch, and sterilized with gamma irradiation to a 10-6 SAL. The SoftSeal-C pad is a non-woven pad composed of chitosan fibers attached to a thin polypropylene backing material. The SoftSeal-C is formed as a 1" by 1" square pad 0.4" thick. The soft, fleece-like pad consists of fine (5 to 20 micrometer) chitosan fibers spun from high molecular weight chitosan. The chitosan fleece is attached to a thin polypropylene backing, which provides dimensional support for fabricating and handling the soft fibers.
    Ask a Question

    Ask a specific question about this device

    K Number
    K090100
    Device Name
    SOFTSEAL-STF
    Manufacturer
    Date Cleared
    2009-03-11

    (55 days)

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

    CHITOGEN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SoftSeal-STF is indicated for use in the management of bleeding wounds such as skin lacerations, vascular access sites, or percutaneous catheter or tube sites. SoftSeal promotes the rapid control of bleeding for patients on hemodialysis and patients on anticoagulation therapy.
    Device Description
    SoftSeal-STF is a sterile topical pad, packaged in a foil pouch, and sterilized with gamma irradiation to a SAL of 10-6.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1