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510(k) Data Aggregation

    K Number
    K140456
    Device Name
    BIO-CONNEKT WOUND MATRIX
    Date Cleared
    2014-07-22

    (148 days)

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

    MLM BIOLOGICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MLM Biologics bio-ConneKt Wound Matrix is a collagen-based wound dressing for the local management of moderately to heavy exuding wounds, including: - · Partial and full thickness wounds - · Draining wounds - Tunneling wounds - Pressure sores/ulcers - Venous ulcers - · Chronic vascular ulcers - Diabetic ulcer · Trauma wounds (e.g., abrasions, lacerations, partial thickness burns, skin tears) · Surgical wounds (e.g., donor sites/grafts, post-laser surgery, post-Mohs' surgery, podiatric wounds, dehisced surgical incisions)
    Device Description
    The bio-ConneKt Wound Matrix is a sterile, conformable and porous wound dressing made of reconstituted collagen derived from equine tendon. It is chemically crosslinked to provide resistance to enzymatic degradation. The dressing is provided sterile for single use only.
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