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

    CELLERATION MIST THERAPY SYSTEM 5.1

    K Number: K050129 · Decision May 17, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    8
    Applicant Total
    3
    Review Days
    118

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    Basic Information

    Device Name
    CELLERATION MIST THERAPY SYSTEM 5.1
    K Number
    K050129
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4410
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Celleration, Inc.
    Date Received
    January 19, 2005
    Decision Date
    May 17, 2005
    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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    Other Clearances by Celleration, Inc.

    K Number Device Name
    K140782 ULTRAMIST SYSTEM, ULTRAMIST GENERATOR, ULTRAMIST TREATMENT WAND, ULTRAMIST APPLICATOR
    K122246 MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12