LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K982051
    Device Name
    KELOCATE SHEETING
    Manufacturer
    ALLIED BIOMEDICAL CORP.
    Date Cleared
    1998-08-05

    (55 days)

    Product Code
    MDA
    Regulation Number
    878.4025
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    KELOCATE SHEETING

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

    This device may be used for the management of Keloid and hypertrophic scars occurring as a result of traumatic injury or surgical procedures. This device is not intended to be used on open wounds. This device is intended for over-the-counter use.

    Device Description

    Kelocote Silicone Sheeting

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the "Kelocote Silicone Sheeting" device. It indicates that the device has been found substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding acceptance criteria or a study proving that the device meets acceptance criteria.

    Therefore, I cannot provide the requested information. The letter primarily addresses the regulatory approval of the device based on substantial equivalence, but it does not detail performance metrics or studies specific to meeting acceptance criteria.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1