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510(k) Data Aggregation

    K Number
    K031094
    Device Name
    FLUID FILLED TEETHERS
    Manufacturer
    ROYAL KING INFANT PRODUCTS CO. LTD.
    Date Cleared
    2003-12-08

    (245 days)

    Product Code
    KKO
    Regulation Number
    872.5550
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    FLUID FILLED TEETHERS

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

    The intended purpose of the fluid filled teether is to relieve the teething discomfort of infants by giving cool soothing effect when the cool teether is chewed on.

    Device Description

    Fluid Filled Teether

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a "Fluid Filled Teether." It states that the device is substantially equivalent to legally marketed predicate devices.

    However, this document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. This type of information is typically found in the 510(k) submission itself, not in the clearance letter.

    Therefore, I cannot provide the requested details based on the provided text. The document confirms that the device is cleared for market due to substantial equivalence, but it does not describe the specific testing or studies that would demonstrate its performance against acceptance criteria.

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