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510(k) Data Aggregation

    K Number
    K974188
    Device Name
    CETYLCIDE-G
    Manufacturer
    Date Cleared
    1998-09-10

    (307 days)

    Product Code
    Regulation Number
    880.6885
    Why did this record match?
    Applicant Name (Manufacturer) :

    KELLER AND HECKMAN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Cetylcide-G is intended for use as a liquid chemical sterilant and/or a high level disinfectant to sterilize and disinfect medical devices and instruments in hospitals, medical, dental, and other healthcare facilities when used according to the directions for use in the package insert. Sterilant: Cetylcide-G is a sterilant when mixed and used in accordance with its directions for use for a maximum of 28 days at 20°C with an immersion time of at least 10 hours at its minimum effective concentration (MEC) of 2.1% glutaraldehyde. High Level Disinfectant: Cetylcide-G is a high level disinfectant when mixed and used according to its directions for use for a maximum of 28 days at 20°C with an immersion time of at least 40 minutes at its minimum effective concentration (MEC) of 2.1% glutaraldehyde.
    Device Description
    Concentrated glutaraldehyde solution for sterilization and high level disinfection (used with diluent solution)
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