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

    PREVENT 0.2 MICRON IV FILTER W/VENT & EXTENSION SE

    K Number: K855065 · Decision Feb 28, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    97
    Applicant Total
    77
    Review Days
    72

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    Basic Information

    Device Name
    PREVENT 0.2 MICRON IV FILTER W/VENT & EXTENSION SE
    K Number
    K855065
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Cobe Laboratories, Inc.
    Date Received
    December 18, 1985
    Decision Date
    February 28, 1986
    Product Code
    FPB
    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
    FPB Filter, Infusion Line

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