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510(k) Data Aggregation

    K Number
    K992345
    Device Name
    CHRISTOUDIAS SLIM TIP ELECTRODE INSERT
    Manufacturer
    Date Cleared
    1999-09-10

    (89 days)

    Product Code
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    INNERVISION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Christoudias Slim Tip Electrode Insert is indicated for laparoscopic surgical procedures where controlling small bleeding vessels with coagulation would be advantageous.
    Device Description
    Not Found
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    K Number
    K991877
    Device Name
    MACMED PAEDIATRIC INTRAMEDULLARY NAIL
    Manufacturer
    Date Cleared
    1999-08-06

    (65 days)

    Product Code
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    INNERVISION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Fracture fixation of long bone diaphysis (tibia, humerus, femur) and fracture reduction at metaphyseal and epiphyseal levels.
    Device Description
    Pediatric Intramedullary Nail
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    K Number
    K982428
    Device Name
    CHRISTOUDIAS GAUZE DISSECTOR (LAPAROSCOPIC HAND INSTRUMENT)
    Manufacturer
    Date Cleared
    1998-10-09

    (88 days)

    Product Code
    Regulation Number
    884.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    INNERVISION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Christoudias Gauze Dissector is indicated for laparoscopic general surgical procedures where blotting small bleeders and/or sponging tissue in a visible, atraumatic world be advantageous.
    Device Description
    Christoudias Gauze Dissector (Laparoscopic Hand Instrument)
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