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510(k) Data Aggregation

    K Number
    K962154
    Device Name
    CARBOMEDICS HANDLE
    Manufacturer
    CARBOMEDICS, INC.
    Date Cleared
    1996-08-27

    (84 days)

    Product Code
    DTJ
    Regulation Number
    870.3935
    Why did this record match?
    Product Code :

    DTJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The reusable CarboMedics Handle is intended for use with the CarboMedics Valve Holder (referred to herein as the "Valve Holder") for the purpose of assuring a firm grasp of the valve and to facilitate sewing ring exposure.
    Device Description
    The reusable CarboMedics Handle is a one-piece, injection molded handle and is provided in one size only. The CarboMedics Handle consists of a threaded polysulfone tip injection molded to a bendable handle. The reusable CarboMedics Handle is manufactured using a polysulfone injection molding process. The CarboMedics Handle consists of a white polysulfone threaded tip injection molded onto a bendable stainless steel shaft, injection molded to a white polysulfone handle. It is supplied non-sterile and must be cleaned and sterilized prior to initial use and each reuse.
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    K Number
    K960169
    Device Name
    CARBOMEDICS VALVE TESTER
    Manufacturer
    CARBOMEDICS, INC.
    Date Cleared
    1996-04-15

    (90 days)

    Product Code
    DTJ
    Regulation Number
    870.3935
    Why did this record match?
    Product Code :

    DTJ

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

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