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

    GC-1000 THROUGH GC-3005 ACID CONCENTRATE

    K Number: K901471 · Decision Jul 27, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    122
    Applicant Total
    3
    Review Days
    121

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    Basic Information

    Device Name
    GC-1000 THROUGH GC-3005 ACID CONCENTRATE
    K Number
    K901471
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Granite Chemical Co., Inc.
    Date Received
    March 28, 1990
    Decision Date
    July 27, 1990
    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 Granite Chemical Co., Inc.

    K Number Device Name
    K901472 GC-BC-01, GC-BC-02, GC-BC-03 BICARBONATE DRY PACKS
    K901473 GC-01 THROUGH GC-99 ACETATE CONCENTRATE