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510(k) Data Aggregation

    K Number
    K963417
    Device Name
    VITLITE (TR7700)
    Date Cleared
    1996-12-20

    (112 days)

    Product Code
    Regulation Number
    876.1500
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ESCALON TREK MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K963434
    Date Cleared
    1996-11-25

    (87 days)

    Product Code
    Regulation Number
    880.5725
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ESCALON TREK MEDICAL

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

    Ask a specific question about this device

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