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510(k) Data Aggregation

    K Number
    K964514
    Device Name
    CORPAK MEDSYSTEMS CRUZ CATHETER FOR PERITONEAL DIALYSIS
    Manufacturer
    CORPAK, INC.
    Date Cleared
    1998-06-26

    (605 days)

    Product Code
    FKO
    Regulation Number
    876.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    CORPAK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The indicated use for the Cruz Catheter is for patients requiring a catheter for long term peritoneal dialysis.
    Device Description
    Cruz™ Catheter
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    K Number
    K970178
    Device Name
    CLOG ZAPPER ENTERAL FEEDING TUBE DECLOGGING SYSTEM
    Manufacturer
    CORPAK, INC.
    Date Cleared
    1997-07-21

    (185 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    CORPAK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Clog Zapper™ Enteral Feeding Tube Decloging System is to clear certain types of blockages, primarily and of of offecal is to crear certain types of blockages, primal enteral formulations, which may occur in enteral feeding tubes.
    Device Description
    Not Found
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