BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    TPN/CVP DRESSING CHANGE KIT

    K Number: K840620 · Decision May 30, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    33
    Applicant Total
    7
    Review Days
    106

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    Basic Information

    Device Name
    TPN/CVP DRESSING CHANGE KIT
    K Number
    K840620
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Marwood Medical, Inc.
    Date Received
    February 14, 1984
    Decision Date
    May 30, 1984
    Product Code
    FMC
    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
    FMC Patient Examination Glove

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    Other Clearances by Marwood Medical, Inc.

    K Number Device Name
    K850340 EYE PROCEDURE PACK
    K850338 EMERGENCY ROOM PACK
    K850339 SPECIAL PROCEDURES PACK
    K850337 CARDIAC CATHETERIZATION PACK
    K850341 CARDIOVASCULAR SET UP
    K840619 I.V. START KIT