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

    MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12

    K Number: K122246 · Decision Aug 13, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    8
    Applicant Total
    3
    Review Days
    17

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    Basic Information

    Device Name
    MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12
    K Number
    K122246
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4410
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Celleration, Inc.
    Date Received
    July 27, 2012
    Decision Date
    August 13, 2012
    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
    K050129 CELLERATION MIST THERAPY SYSTEM 5.1