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510(k) Data Aggregation

    K Number
    K023283
    Device Name
    1075LD HUSH-SLUSH
    Manufacturer
    O.R. SOLUTIONS, INC.
    Date Cleared
    2002-11-13

    (43 days)

    Product Code
    LHC
    Regulation Number
    890.5950
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    1075LD HUSH-SLUSH

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

    The ORS-1075LD is designed to cool surgical irrigation solutions and/or create slush.

    Device Description

    Not Found

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. It is a 510(k) clearance letter from the FDA for a device called "1075LD Hush-Slush®," primarily addressing its substantial equivalence to predicate devices and outlining regulatory obligations.

    Therefore, I cannot provide the requested table or answer the questions regarding study details, sample sizes, expert qualifications, or ground truth establishment.

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