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

    SECONDARY I.V. TUBING SETS

    K Number: K800878 · Decision Jun 17, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    424
    Registration Numbers
    424
    Same Product Code
    1173
    Applicant Total
    8
    Review Days
    61

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    Basic Information

    Device Name
    SECONDARY I.V. TUBING SETS
    K Number
    K800878
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Harvard Laboratories
    Date Received
    April 17, 1980
    Decision Date
    June 17, 1980
    Product Code
    FPA
    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
    FPA Set, Administration, Intravascular

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    Other Clearances by Harvard Laboratories

    K Number Device Name
    K822765 SIGMOIDOSCOPE, FLEXIBLE
    K810573 TUBE FEEDING SET
    K810574 SUCTION COLLECTION BOTTLE, DISPOSABLE
    K800879 CLEAR PLASTIC CONNECTING TUBES
    K800877 ANESTHESIA EXTENSION TUBES
    K800880 PLASTIC TUBING ADAPTERS 5-IN-1-
    K800881 DISPOSABLE BERMAN AIRWAYS