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510(k) Data Aggregation

    K Number
    K040439
    Device Name
    MDI TRIGGER GUARD
    Manufacturer
    NORTH AMERICAN TECHNICAL SERVICES (NATS) CORP.
    Date Cleared
    2004-07-08

    (140 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    NORTH AMERICAN TECHNICAL SERVICES (NATS) CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MDI Trigger Guard serves as a mechanical stop intended to be used with FDA approved metered dose inhalers. The MDI Trigger Guard is an accessory to a metered dose inhaler to prevent accidental actuation. Intended for use by entire patient population for which metered dose inhalers are approved, excluding children under the age of 8. Device is not reusable. Device is to be used for the life of the metered dose inhaler, then discarded.
    Device Description
    The MDI Trigger Guard serves as a mechanical stop intended to be used with FDA approved metered dose inhalers. The MDI Trigger Guard is an accessory to a metered dose inhaler to prevent accidental actuation.
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