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510(k) Data Aggregation

    K Number
    K964783
    Device Name
    EPIDURAL MINI KIT, ELDOR COMBINED SPINAL/EPIDURAL KIT
    Manufacturer
    ALEXANDER MEDICAL, INC.
    Date Cleared
    1997-02-12

    (77 days)

    Product Code
    CAZ
    Regulation Number
    868.5140
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALEXANDER MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Delivery of Epidural anesthesia for the epidural kits and delivery of combined spinal/epidural anesthesia for the combined kits.
    Device Description
    The Epidural kit includes an epidural needle (Eldor combined spinal/epidural), epidural catheter, Touhy-Borst Adapter, Loss of resistance syringe, and Epidural. The epidural/spinal combined Kit includes the same components and adds a pencil point spinal needle.
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