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510(k) Data Aggregation

    K Number
    K091198
    Device Name
    LIQUID FILLED RING TEETHER, MODEL 03807, LIQUID FILLED RING TEETHER, MODELS 1962005, 1962011, LIQUID FILLED TEETHING
    Manufacturer
    ALLIED HILL ENTERPRISES, LTD.
    Date Cleared
    2009-12-07

    (227 days)

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

    ALLIED HILL ENTERPRISES, LTD.

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

    The Water Filled Teether is used for the temporary relief of pain and discomfort in infants and toddlers caused by teething.

    Device Description

    Water Filled Teether

    AI/ML Overview

    I am sorry, but this document contains no information about acceptance criteria or study results for a medical device. The document is a 510(k) premarket notification letter from the FDA to Allied Hill Enterprises, Limited, regarding a "Water Filled Teether." It primarily discusses the substantial equivalence determination for the device and regulatory requirements.

    Therefore, I cannot provide the requested information.

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