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

    DRESSING CHANGE TRAY-MEDIUM

    K Number: K802954 · Decision Dec 17, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    15
    Applicant Total
    29
    Review Days
    27

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    Basic Information

    Device Name
    DRESSING CHANGE TRAY-MEDIUM
    K Number
    K802954
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5630
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Associated Medical Products Co.
    Date Received
    November 20, 1980
    Decision Date
    December 17, 1980
    Product Code
    FKO
    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
    FKO Catheter, Peritoneal Dialysis, Single Use

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    Other Clearances by Associated Medical Products Co.

    K Number Device Name
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    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
    K823839 AMPCO KIDNEY DIALYSIS TRAY
    Search all 29 clearances from Associated Medical Products Co. →