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510(k) Data Aggregation

    K Number
    K971473
    Device Name
    IVALON INSTRUMENT WIPE, IVALON KNIFE CLEANING BLOCK
    Manufacturer
    M-PACT WORLDWIDE MANAGEMENT CORP.
    Date Cleared
    1997-07-07

    (75 days)

    Product Code
    GEC,GER
    Regulation Number
    878.4800
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    IVALON INSTRUMENT WIPE, IVALON KNIFE CLEANING BLOCK

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

    The Ivalon® Instrument Wipe and PVA Knife Cleaning Block are used to clean surgical instruments and knives.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for the Ivalon Instrument Wipe and Ivalon Knife Cleaning Block. It does not contain any information regarding acceptance criteria or a study that proves the device meets acceptance criteria.

    The document is a notification of an administrative change related to a previous substantial equivalence (SE) determination, and the initial SE letter itself. These documents confirm that the devices are substantially equivalent to devices marketed prior to May 28, 1976, or reclassified devices, and therefore can be marketed. They discuss regulatory compliance such as annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

    Therefore, I cannot provide the requested information as it is not present in the given text.

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