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510(k) Data Aggregation

    K Number
    K990711
    Device Name
    CODAN CHEMOSPIKE
    Manufacturer
    CODAN US CORP.
    Date Cleared
    1999-04-13

    (40 days)

    Product Code
    LHI
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CODAN CHEMOSPIKE

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

    The CODAN Chemospike is a transfer pin system for the safe preparation and withdrawal of medication and cytotoxic agents. It is designed to prevent the withdrawar of modication aring reconstitution of the drug in the vial and withdrawal of the drug from the vial.

    Device Description

    CODAN Chemospike

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA to a medical device manufacturer (CODAN US Corporation) regarding the substantial equivalence of their "CODAN Chemospike" device to a predicate device. This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies that would allow me to populate the requested table and answer the study-related questions.

    The document primarily focuses on regulatory approval based on substantial equivalence, which is a different type of assessment than a performance study with detailed acceptance criteria.

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