LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K040403
    Device Name
    COLLAGEN WOUND DRESSING - ORAL
    Manufacturer
    COLLAGEN MATRIX, INC.
    Date Cleared
    2004-05-10

    (83 days)

    Product Code
    KGN
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K994339,K030921
    Why did this record match?
    Device Name :

    COLLAGEN WOUND DRESSING - ORAL

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

    Collagen Wound Dressing - Oral is indicated for the management of oral wounds and sores, including:

    • Denture sores
    • Oral ulcers (non-infected or viral)
    • Periodontal surgical wounds
    • Suture sites
    • Burns
    • Extraction sites
    • Surgical wounds
    • Traumatic wounds
    Device Description

    Collagen Wound Dressing - Oral is a white to off-white, absorbent, microfibrillar collagen matrix. The product is supplied sterile and for single use only.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) summary for a Collagen Wound Dressing-Oral, which is a regulatory document from the FDA. It discusses the device's classification, indications for use, and substantial equivalence to predicate devices, but it does not include details on performance studies with acceptance criteria, sample sizes, expert qualifications, or ground truth methodologies.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1