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

    STERILE SALINE - FOR SUCTION CATHETER LUBRICATION

    K Number: K895039 · Decision Oct 3, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    193
    Registration Numbers
    193
    Same Product Code
    86
    Applicant Total
    9
    Review Days
    55

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    Basic Information

    Device Name
    STERILE SALINE - FOR SUCTION CATHETER LUBRICATION
    K Number
    K895039
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6740
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Aplicare, Inc.
    Date Received
    August 9, 1989
    Decision Date
    October 3, 1989
    Product Code
    GCX
    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
    GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered

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