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510(k) Data Aggregation

    K Number
    K994021
    Device Name
    CONTACLAIR MULTI-PURPOSE CONTACT LENS SOLUTION
    Manufacturer
    STRIETER CLINICAL RESEARCH LABORATORIES, INC.
    Date Cleared
    2000-02-22

    (88 days)

    Product Code
    LYL
    Regulation Number
    886.5928
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    STRIETER CLINICAL RESEARCH LABORATORIES, INC.

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

    ContaClair® Multi-Purpose Solution is indicated for use in cleaning, rinsing, disinfecting, protein removal and storing daily and extended wear soft (hydrophilic) and RGP (rigid gas permeable) contact lenses as recommended by your practitioner. ContaClair is indicated for use in chemical (not heat) lens care regimen.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a multi-purpose contact lens solution called ContaClair®. It does not contain information about acceptance criteria or a study proving that a device (in the context of an AI/ML medical device) meets acceptance criteria. The product is a chemical solution, not a software or hardware device that would typically involve acceptance criteria and a study as requested.

    Therefore, I cannot provide the requested information based on the input text. The provided document is a regulatory approval for a contact lens care product, not a description of a device's performance study.

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