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

    SODIUM BICARBONATE, U.S.P.

    K Number: K891159 · Decision Apr 7, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    122
    Applicant Total
    5
    Review Days
    32

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    Basic Information

    Device Name
    SODIUM BICARBONATE, U.S.P.
    K Number
    K891159
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Williams Medical Co.
    Date Received
    March 6, 1989
    Decision Date
    April 7, 1989
    Product Code
    KPO
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

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    Other Clearances by Williams Medical Co.

    K Number Device Name
    K854031 SNAP-LOCK ADDITIVE CAP #SL100
    K854033 SNAP-LOCK ADDITIVE CAP #SL400
    K854034 SNAP-LOCK ADDITIVE CAP #SL 300
    K854032 SNAP-LOCK ADDITIVE CAP #SL 200