BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    CAVITY DRAINAGE CATHETERIZATION SET, CS-01600

    K Number: K895516 · Decision Dec 27, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    243
    Registration Numbers
    243
    Same Product Code
    76
    Applicant Total
    110
    Review Days
    106

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    Basic Information

    Device Name
    CAVITY DRAINAGE CATHETERIZATION SET, CS-01600
    K Number
    K895516
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4200
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Arrow Intl., Inc.
    Date Received
    September 12, 1989
    Decision Date
    December 27, 1989
    Product Code
    GBX
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GBX Catheter, Irrigation

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