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

    MEGA DRESSING CHANGE KIT

    K Number: K910363 · Decision Mar 28, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    23
    Applicant Total
    50
    Review Days
    58

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    Basic Information

    Device Name
    MEGA DRESSING CHANGE KIT
    K Number
    K910363
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5075
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Megadyne Medical Products, Inc.
    Date Received
    January 29, 1991
    Decision Date
    March 28, 1991
    Product Code
    MCY
    Advisory Committee
    General Hospital
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MCY Wound Dressing Kit

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