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510(k) Data Aggregation

    K Number
    K011789
    Device Name
    PROCEDURE MASKS: PM4-301 AND PM4-304
    Manufacturer
    PRIMELINE MEDICAL PRODUCTS, INC.
    Date Cleared
    2001-06-22

    (14 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Special
    Panel
    General Hospital
    Reference & Predicate Devices
    K001951
    Why did this record match?
    Device Name :

    PROCEDURE MASKS: PM4-301 AND PM4-304

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

    Surgical Masks are surgical apparel, identified in 21 CFR, part 878.4040, as a medical device intended to be world by operating room personnel from the transfer of protect bour the barger fluids, and particulate matcrial.

    Device Description

    Procedure Masks PM 4-301 + Pm4-31

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter from the FDA regarding "Procedure Masks: PM4-301 and PM4-304" manufactured by Primline Medical Products, Incorporated. It confirms that the device is substantially equivalent to a legally marketed predicate device.

    The provided text does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details. It is a regulatory approval document, not a study report.

    Therefore, I cannot provide the requested information from the given input.

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