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

    JACKSON-PRATT, HIGH LUBRICITY AND WOUND DRAINS

    K Number: K905614 · Decision Mar 20, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    243
    Registration Numbers
    243
    Same Product Code
    76
    Applicant Total
    505
    Review Days
    96

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    Basic Information

    Device Name
    JACKSON-PRATT, HIGH LUBRICITY AND WOUND DRAINS
    K Number
    K905614
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4200
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Baxter Healthcare Corp
    Date Received
    December 14, 1990
    Decision Date
    March 20, 1991
    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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