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510(k) Data Aggregation

    K Number
    K971517
    Device Name
    SILICONE PUTTY EAR PLUGS
    Manufacturer
    BENTEC MEDICAL, INC.
    Date Cleared
    1997-06-02

    (38 days)

    Product Code
    EWD
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SILICONE PUTTY EAR PLUGS

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

    Silicone Putty Ear Plugs are used to block water from entering the ear canal.

    Device Description

    Silicone Putty Ear Plugs

    AI/ML Overview

    This document is a 510(k) clearance letter for "Silicone Putty Ear Plugs" (K071517). It indicates that the device is substantially equivalent to legally marketed predicate devices. However, this type of regulatory correspondence does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.

    Therefore, I cannot provide the requested information based solely on the provided text. The letter is a regulatory approval document, not a scientific study report.

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