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510(k) Data Aggregation

    K Number
    K962959
    Device Name
    PERACIDIN DIALYZER REPROCESSING CONCENTRATE
    Manufacturer
    HDC MEDICAL, INC.
    Date Cleared
    1998-06-05

    (675 days)

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

    HDC MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Peracidin™ Dialyzer Reprocessing Concentrate is indicated for the in-virro cleaning and disinfection of hollow fiber dialyzers, classified as follows: Conventional dialyzer, 21 CFR 876.5820, product code 78 FJI High permeability dialyzer, 21 CFR 876,5860, product code 78 KDI The product is intended for use only with reprocessing systems, automated or manual, that have been validated by the system manufacturer for use with peracetic acid. The intended use of Peracidin is identical to that of Renalin.
    Device Description
    Peracidial Dialyzer Reprocessing Concentrate is a stabilized mixture of hydrogen peroxide 27,0% and peroxyacetic acid 4,5%; inert ingredients are 68,5% (nominal concentrations). The concentrate is a clear colorless liquid, is highly acidic, and is completely soluble in water. Peracidim breaks down to acetic acid, water, and oxygen.
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