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510(k) Data Aggregation

    K Number
    K100208
    Device Name
    IMC SURGICAL DRAPE
    Manufacturer
    INTERNATIONAL MEDSURG CONNECTION
    Date Cleared
    2010-04-20

    (85 days)

    Product Code
    KKX
    Regulation Number
    878.4370
    Type
    Special
    Panel
    General Hospital
    Reference & Predicate Devices
    K052169
    Why did this record match?
    Reference Devices :

    K052169

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

    This device is intended to be used as protective coverings used to isolate incision sites and protect against contamination during surgical procedures.

    Device Description

    International Medsurg Connection's Surgical Drape is intended to be used as protective coverings used to isolate incision sites and protect against contamination during surgical procedures. This submission includes drapes that will be sold both sterile and non-sterile. Non-sterile drapes are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile drapes are to be sold directly to users according to current sterilization process.

    AI/ML Overview

    This document is a 510(k) premarket notification for "IMC-Surgical Drapes - Various Types, Sizes and Configurations." As such, it does not contain information related to the performance of an AI/ML powered device, or a study to prove such performance.

    Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving a device meets those criteria because the provided text does not describe such a device or study.

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