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510(k) Data Aggregation

    K Number
    K161013
    Device Name
    InnoSEAL Hemostatic Pad
    Manufacturer
    Date Cleared
    2016-11-29

    (232 days)

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

    InnoTherapy Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    InnoSEAL Hemostatic Pad is intended for the local management of bleeding wounds and for the promotion of rapid control of bleeding. InnoSEAL Hemostatic Pad is intended for use under the care of a healthcare professional. The dressing is indicated for following wounds; lacerations, abrasions and the skin surface puncture sites for vascular procedures, percutaneous catheters/tubes.
    Device Description
    InnoSEAL Hemostatic Pad is a hydrophilic, lyophilized sponge pad for local management of bleeding wound made of proprietary formulation of chitosan and catechol conjugated chitosan which are biocompatible. InnoSEAL Hemostatic Pad is applied topically as an adjunct to manual compression. InnoSEAL Hemostatic Pad is a single use device individually packaged by PET mold and Aluminum lid and sterilized with gamma irradiation.
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