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

    CODAN CHEMOSPIKE

    K Number: K990711 · Decision Apr 13, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    205
    Applicant Total
    7
    Review Days
    40

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    Basic Information

    Device Name
    CODAN CHEMOSPIKE
    K Number
    K990711
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Codan US Corp.
    Date Received
    March 4, 1999
    Decision Date
    April 13, 1999
    Product Code
    LHI
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LHI Set, I.V. Fluid Transfer

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    Other Clearances by Codan US Corp.

    K Number Device Name
    K112268 CODAN SAFEFEED ENTERAL FEEDING RESERVOIR
    K042693 IV ADMINISTRATION SET B400 SP
    K033301 IV ADMINISTRATION AND CONNECT SETS
    K021480 EXTENSION SET LIGHT-SAFE, MODEL BC565
    K013714 CODAN US I.V. ADMINISTRATION SET, MODEL B400 SP
    K001872 I.V. SET-LUER LOCK WITH LATEX FREE INJECTION SITE, MODEL B411