BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ATRION EPIDURAL ANESTHESIA KIT WITH ATRION NEEDLEVISE SHARPS SECURING SYSTEM

    K Number: K041158 · Decision Jun 16, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    81
    Registration Numbers
    81
    Same Product Code
    154
    Applicant Total
    9
    Review Days
    44

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    Basic Information

    Device Name
    ATRION EPIDURAL ANESTHESIA KIT WITH ATRION NEEDLEVISE SHARPS SECURING SYSTEM
    K Number
    K041158
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5140
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Atrion Medical Products, Inc.
    Date Received
    May 3, 2004
    Decision Date
    June 16, 2004
    Product Code
    CAZ
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    CAZ Anesthesia Conduction Kit

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