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510(k) Data Aggregation

    K Number
    K213092
    Device Name
    Cellusheet, Cellufil
    Manufacturer
    Human Biosciences, Inc.
    Date Cleared
    2021-12-15

    (82 days)

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

    Human Biosciences, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for the management of minor scrapes, minor bruises, minor abrasions, minor lacerations, and minor burns.
    Device Description
    Cellusheet Dressing is a soft, sterile, disposable, absorbent & conformable single use wound dressing. It is hydrophilic dressing composed of fibrous bovine collagen and a non-adherent backing layer. The dressing absorbs wound drainage to cover the topical wounds to provide moist wound environment. The Cellusheet Dressing will be available in 2"X2" and 8"X12" sizes. Cellusheet Dressing is made up of collagen which is the most abundant protein in the human body and to cover the topical wounds to provide moist wound environment. Cellufil Particles is a bovine (cattle) collagen wound dressing that is sterile, off-white powder that absorbs wound drainages. The dressing is an off-white, colored powder made up of collagen cover the topical wounds to provide moist wound environment. Cellufil Particles consists of spherical hydrophilic particles 0.1mm to 0.3mm in diameter.
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    K Number
    K122325
    Device Name
    SKINTEMP II
    Manufacturer
    HUMAN BIOSCIENCES, INC.
    Date Cleared
    2012-10-26

    (86 days)

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

    HUMAN BIOSCIENCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for the management of burns, sores, blisters, scrapes, ulcers, and other wounds.
    Device Description
    Skin Temp. H. Dressing is a sterile, disposable, single use wound dressing. It is a hydrocolloid and hydrophillic dressing composed of fibrous type I bovine collagen. The device is to be provided in hydrated as well as dry form. The device is to be used for the management of burns, blisters, sores, scrapes, ulcers and other wounds. The Skin.Temp. II. Dressing will be available in 2"X2", 3"X4" and 8"X12" sizes and additional sizes may introduced at a later time.
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