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510(k) Data Aggregation

    K Number
    K082703
    Device Name
    MRDH BANDAGE
    Manufacturer
    MARINE POLYMER TECHNOLOGIES, INC.
    Date Cleared
    2008-10-14

    (28 days)

    Product Code
    KMF
    Regulation Number
    880.5090
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K002550,K013225,K061722
    Why did this record match?
    Device Name :

    MRDH BANDAGE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    mRDH Bandage™ is a trauma dressing intended for the temporary control of severely bleeding wounds such as surgical wounds (operative, postoperative, donor sites, dermatological, etc.) and traumatic injuries.

    Device Description

    mRDH Bandage " is a soft. white, sterile non-woven lyophilized pad of a cellulosic polymer isolated from microalgae (poly-N-acetylglucosamine). It is attached to x-ray detectable gauze and packaged in a sterile blister pack. mRDH Bandage" is available as a 4in x 4in (10cm x 10cm) bandage.

    AI/ML Overview

    I am sorry, but this document contains no information about acceptance criteria or the study that proves the device meets those criteria. It is a 510(k) summary and approval letter which focuses on establishing substantial equivalence to a predicate device. Therefore, I cannot extract the requested details.

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