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

    CELLERATION MIST THERAPY SYSTEM

    K Number: DEN040004 · Decision Jun 25, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    8
    Applicant Total
    1
    Review Days
    57

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    Basic Information

    Device Name
    CELLERATION MIST THERAPY SYSTEM
    K Number
    DEN040004
    Device Class
    FDA class 2
    Clearance Type
    Post-NSE
    Regulation Number
    878.4410
    Medical Specialty
    General, Plastic Surgery
    Decision
    Unknown
    Applicant
    Celleration
    Date Received
    April 29, 2004
    Decision Date
    June 25, 2004
    Product Code
    NRB
    Advisory Committee
    General, Plastic Surgery
    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
    NRB Wound Cleaner, Ultrasound

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