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510(k) Data Aggregation

    K Number
    K981549
    Device Name
    LACTATION TECHNIQUES MODEL B
    Manufacturer
    LACTATION TECHNIQUES, INC.
    Date Cleared
    1999-05-24

    (389 days)

    Product Code
    HGX
    Regulation Number
    884.5160
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Lactation Techniques TM Model B auto cycling breast pump is to aid nursing mothers at home with the extraction of breast milk in the absence of the nursing child due to illness or other situations causing temporary separation.

    Device Description

    Lactation Techniques™Model B Powered Breast Pump

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a breast pump, specifically the Lactation Techniques™ Model B Powered Breast Pump. It does not contain any information regarding acceptance criteria, study details, or device performance data.

    Therefore, I cannot provide the requested information. The letter only confirms that the FDA has determined the device is substantially equivalent to legally marketed predicate devices and can proceed to market.

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