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510(k) Data Aggregation

    K Number
    K971015
    Device Name
    AHCS HEMOPERFUSION SYSTEM
    Manufacturer
    AMERICAN HEALTH CARE SYSTEMS, INC.
    Date Cleared
    1997-10-22

    (216 days)

    Product Code
    FLD
    Regulation Number
    876.5870
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMERICAN HEALTH CARE SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Blood detoxification and drug removal/retention
    Device Description
    AHCS Hemoperfusion System
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