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510(k) Data Aggregation

    K Number
    K991719
    Device Name
    EPISTAR/EPISTAR CSE SPINAL/EPIDURAL ANESTHESIA ADMINISTRATION SETS
    Date Cleared
    1999-08-18

    (90 days)

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

    **MEDIMEX HOLFELD GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    - The MEDIMEX Epistar CSE kit is intended for administration of epidural anesthesia that may be combined with a spinal aneshetic. The MEDIMEX Epistar CSE kit I is intended for single epidural infections for use enidural ansthesia, for of the MEDIMEX catherer in the CSE kit for continuous epidural needle is also inten of the MEDIMEX catheter in the CSE Kit for continuous condum and our and on allow catheterization duration of up to 72 hours. The CSE epidural needle is also intended to allo catheterization duration of up to 72 nouts. The CSL cpace to provide anesthesia passage of a pencil point-spinal needle into the intratesal space to provide anesthesia passage of a pencil point-spinal needle into intrallect. The MEDIMEX Epistar immediately before or after placement of the epidural parties only to provi immediately before or atter placement of the epiddral needle, is intended only to provide epidural kit containing the conventional epistar epidural space for epidural kit containing the conventional epistal epistal collection of the epidural space for up to 72 hours. - Prescription use
    Device Description
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