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510(k) Data Aggregation

    K Number
    K012196
    Device Name
    ULTRACELL ABSORBENT STICK
    Manufacturer
    ULTRACELL MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    2001-08-24

    (42 days)

    Product Code
    HOZ
    Regulation Number
    886.4790
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ULTRACELL ABSORBENT STICK

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

    Used during surgery to protect delicate tissue from trauma, absorb fluid and act as a filter to aspirate.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the "Ultracell Absorbent Stick." This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in the prompt. It is a regulatory approval document confirming substantial equivalence to a predicate device, not a technical report detailing performance studies.

    Therefore, I cannot provide the requested information based on the input text.

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