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510(k) Data Aggregation

    K Number
    K032832
    Device Name
    IRRIGATION SETS
    Manufacturer
    VITAL CONCEPTS, INC.
    Date Cleared
    2003-09-26

    (15 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    VITAL CONCEPTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vital Concepts Irrigation Sets are intended for the delivery of irrigation solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic procedures including cystoscopy, transurethral resection (TUR) and arthroscopic procedures.
    Device Description
    Not Found
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    K Number
    K960616
    Device Name
    VITAFLOW SUCTION/ASPIRATION TUBING SET
    Manufacturer
    VITAL CONCEPTS, INC.
    Date Cleared
    1996-05-06

    (83 days)

    Product Code
    BYY
    Regulation Number
    880.6740
    Why did this record match?
    Applicant Name (Manufacturer) :

    VITAL CONCEPTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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