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

    AMPCO KIDNEY DIALYSIS TRAY

    K Number: K823839 · Decision Mar 29, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    181
    Applicant Total
    29
    Review Days
    98

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    Basic Information

    Device Name
    AMPCO KIDNEY DIALYSIS TRAY
    K Number
    K823839
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Associated Medical Products Co.
    Date Received
    December 21, 1982
    Decision Date
    March 29, 1983
    Product Code
    KOC
    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
    KOC Accessories, Blood Circuit, Hemodialysis

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    Other Clearances by Associated Medical Products Co.

    K Number Device Name
    K932221 NEUROLOGICAL OR CRANI TRAYS (PACKS)
    K932216 C-SECTION, LABOR & DELIVERY TRAYS (PACKS)
    K930507 CUSTOM ORTHOPAEDIC TRAYS (PACKS)
    K932217 MAJOR, MINOR, BASIN TRAYS (PACKS)
    K932220 LAP CHOLY TRAYS (PACKS)
    K932218 CARDIAC CATH OR ANGIOGRAPHIC TRAYS
    K932219 SUTURE SET OR LACERATION TRAYS (PACKS)
    K842983 AMPCO OPTHALMIC TRAY
    K843114 AMPCO PROCEDURE TRAYS / PACKS
    K821579 SKIN SCRUB-TRAY
    Search all 29 clearances from Associated Medical Products Co. →