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510(k) Data Aggregation

    K Number
    K982648
    Device Name
    JOAN II
    Manufacturer
    CELANESE ACETATE CO.
    Date Cleared
    1998-09-30

    (63 days)

    Product Code
    EFQ,EFO
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    CELANESE ACETATE CO.

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

    JoAn II ™ is designed for external application for use in absorbing fluids.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a device named "JoAn II™," which is described as being "designed for external application for use in absorbing fluids." This document does not contain any information regarding acceptance criteria, device performance studies, or details about ground truth establishment, expert qualifications, or sample sizes for training or testing.

    Therefore, I cannot provide the requested information. The letter only confirms that the device has been found substantially equivalent to a pre-amendment device and can be legally marketed.

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