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

    DRESSING CHANGE KIT

    K Number: K850887 · Decision May 1, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    7
    Review Days
    58

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    Basic Information

    Device Name
    DRESSING CHANGE KIT
    K Number
    K850887
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Creative Care Systems, Inc.
    Date Received
    March 4, 1985
    Decision Date
    May 1, 1985
    Product Code
    FOZ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

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    Other Clearances by Creative Care Systems, Inc.

    K Number Device Name
    K861406 NON-KOR WINGED INFUSION SETS
    K852831 NON-KOR ACCESS KITS
    K850888 PERCUTANEOUS CV CATHETER INSERTION KIT W OR W/O CV
    K841742 NON-CORING NEEDLE
    K840919 DAYPAK SYS VII CATHETER CARE KIT
    K840681 DAYPAK SYSTEM III CATHETER CARE KIT