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

    SPECIAL PROCEDURES PACK

    K Number: K850339 · Decision Mar 12, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    424
    Registration Numbers
    424
    Same Product Code
    1173
    Applicant Total
    7
    Review Days
    43

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    Basic Information

    Device Name
    SPECIAL PROCEDURES PACK
    K Number
    K850339
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Marwood Medical, Inc.
    Date Received
    January 28, 1985
    Decision Date
    March 12, 1985
    Product Code
    FPA
    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
    FPA Set, Administration, Intravascular

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    Other Clearances by Marwood Medical, Inc.

    K Number Device Name
    K850340 EYE PROCEDURE PACK
    K850338 EMERGENCY ROOM PACK
    K850337 CARDIAC CATHETERIZATION PACK
    K850341 CARDIOVASCULAR SET UP
    K840620 TPN/CVP DRESSING CHANGE KIT
    K840619 I.V. START KIT