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510(k) Data Aggregation

    K Number
    K103321
    Device Name
    DANA REUSABLE TESTPACK FOR STEAM STERILIZATION FOR 10 MINUTE EXTENDED CYCLES
    Manufacturer
    DANA PRODUCTS, INC.
    Date Cleared
    2011-02-16

    (96 days)

    Product Code
    FRC
    Regulation Number
    880.2800
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K092944
    Why did this record match?
    Device Name :

    DANA REUSABLE TESTPACK FOR STEAM STERILIZATION FOR 10 MINUTE EXTENDED CYCLES

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

    The disposable polypropylene sleeve assembly with 3M's 1292 Bl used with the Dana Reusable Test Pack can be used for routine monitoring of 10 Minute 270° F pre-vacuum steam sterilization cycles. The polypropylene sleeve assembly is intended to be used only with Dana Reusable Test Pack cleared under K 092944.

    Device Description

    Reusable Biological Indicator Test Pack for Steam Sterilization.

    AI/ML Overview

    The provided document (K103321) is a 510(k) clearance letter from the FDA for a Reusable Biological Indicator Test Pack for Steam Sterilization. It indicates substantial equivalence to a predicate device. However, this document does not contain the detailed study information, acceptance criteria, or performance data typically found in a summary or report of a scientific study.

    Therefore, I cannot provide the requested information from the given text. A 510(k) summary or a more detailed technical report would be needed to answer these questions.

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