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510(k) Data Aggregation

    K Number
    K141330
    Device Name
    ENDO-CORD
    Manufacturer
    ENROXTECH, INC.
    Date Cleared
    2014-12-15

    (208 days)

    Product Code
    FST
    Regulation Number
    878.4580
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENROXTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to transmit light for illumination purposes from the light source to endoscopes.
    Device Description
    A 5mm fiber-optic light transmitting core with durable protective sleeve and stainless steel couplings at each end. One coupling is for the light source and the opposite end for connection to an endoscope. The core is inserted into a durable and reusable silicone rubber sheath. One length is available: 7.5 Feet. Field replaceable fiber-optic core.
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