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

    CENTURION KLEEN-NEEDLE SYSTEM I.V. EXTENSION SETS

    K Number: K910906 · Decision Apr 1, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66
    Same Product Code
    63
    Applicant Total
    16
    Review Days
    27

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    Basic Information

    Device Name
    CENTURION KLEEN-NEEDLE SYSTEM I.V. EXTENSION SETS
    K Number
    K910906
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Tri-State Hospital Supply Corp.
    Date Received
    March 5, 1991
    Decision Date
    April 1, 1991
    Product Code
    FPK
    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
    FPK Tubing, Fluid Delivery

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    K931748 CENTLURION DISP STERI DENTAL/HYGIENE PACK/TRAYS
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