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510(k) Data Aggregation

    K Number
    K151562
    Device Name
    Resultz Lice & Egg Removal Kit
    Manufacturer
    Piedmont Pharmaceuticals, LLC
    Date Cleared
    2017-05-08

    (698 days)

    Product Code
    LJL
    Regulation Number
    880.5960
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Piedmont Pharmaceuticals, LLC

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

    The Resultz® Lice & Egg Removal Kit is intended to be used to remove head lice and their eggs from hair. The kit contains a fine-toothed nit comb and cosmetic based combing aid.

    Device Description

    The kit contains a fine-toothed nit comb and cosmetic based combing aid.

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding a lice and egg removal kit. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device.

    The document is purely administrative, confirming the substantial equivalence of the "Resultz® Lice & Egg Removal Kit" to a legally marketed predicate device. It specifies the product's intended use and regulatory classification.

    Therefore, I cannot provide the requested information based on the given input. The categories in your request (e.g., sample size for test set, number of experts, MRMC study, ground truth) are standard for AI/ML device evaluations, which are not discussed in this document.

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