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510(k) Data Aggregation

    K Number
    K030334
    Device Name
    T-SCIENTIFIC T-PAD
    Manufacturer
    T-SCIENTIFIC, INC.
    Date Cleared
    2003-04-21

    (80 days)

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

    T-SCIENTIFIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The T-Scientific T-Pad™ is intended for use in the: - 1. Local management of bleeding wounds such as lacerations, abrasions, nose bleeds, vascular access site, percutaneous catheters or tubes and surgical debridement, and - 2. The promotion of rapid control of bleeding in patients following hemodialysis and in patients on anticoagulation therapy.
    Device Description
    The T-Scientific T-Pad™ is a soft, non-woven pad of poly-N-acetylglucosamine. T-Pad™ is packed in a foil pouch and sterilized by E-beam radiation to a 10-6 SAL.
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