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510(k) Data Aggregation

    K Number
    K040707
    Device Name
    PACKAGING TRAY AND COMPONENTS
    Manufacturer
    VYGON US LLC
    Date Cleared
    2004-04-16

    (29 days)

    Product Code
    FRG
    Regulation Number
    880.6850
    Type
    Special
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The packaging tray is intended to be used as a non-reusable protective pack, which allows EO sterilization of the product and maintains sterility for a specified length of time, and protects the product from damage during transport, delivery and storage.

    Device Description

    Packaging Tray and Accessories

    AI/ML Overview

    This is a 510(k) clearance letter for a "Packaging Tray and Accessories" (K040707) and its indications for use. This document confirms the device's substantial equivalence to a predicate device but does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.

    Therefore, I cannot extract the requested information regarding acceptance criteria and study details from this document. This letter is an administrative approval of market clearance, not a performance study report.

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