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510(k) Data Aggregation

    K Number
    K021288
    Device Name
    ORS-1000LD
    Manufacturer
    O.R. SOLUTIONS, INC.
    Date Cleared
    2002-06-27

    (65 days)

    Product Code
    LHC
    Regulation Number
    890.5950
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    K142080,K142173,K152522
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ORS-1000LD Leak Detection Drape is an equipment cover for the ORS-2000LD Solution Warmer. This is a single use product supplied sterile. This device is intended for use during various surgeries where warm irrigation solution is required.

    Device Description

    The ORS-1000LD Leak Detection Drape is an equipment cover for the ORS-2000LD Solution Warmer. This is a single use product supplied sterile.

    AI/ML Overview

    This document is a 510(k) clearance letter for the ORS-1000LD Leak Detection Drape. It asserts substantial equivalence to a predicate device and outlines regulatory compliance, but it does not contain information about acceptance criteria or a study proving the device meets those criteria.

    Therefore, I cannot provide the requested table and information as these details are not present in the provided text. The letter is a regulatory approval document, not a performance study report.

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