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510(k) Data Aggregation

    K Number
    K140782
    Device Name
    ULTRAMIST SYSTEM, ULTRAMIST GENERATOR, ULTRAMIST TREATMENT WAND, ULTRAMIST APPLICATOR
    Manufacturer
    CELLERATION, INC.
    Date Cleared
    2014-08-13

    (135 days)

    Product Code
    NRB
    Regulation Number
    878.4410
    Why did this record match?
    Applicant Name (Manufacturer) :

    CELLERATION, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MIST Systems produce a low energy ultrasound-generated mist used to promote wound healing through wound cleansing and maintenance debridement by the removal of fibrin, yellow slough, tissue exudates and bacteria.
    Device Description
    Not Found
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    K Number
    K122246
    Device Name
    MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12
    Manufacturer
    CELLERATION, INC.
    Date Cleared
    2012-08-13

    (17 days)

    Product Code
    NRB
    Regulation Number
    878.4410
    Why did this record match?
    Applicant Name (Manufacturer) :

    CELLERATION, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MIST Therapy System produces a low energy ultrasound generated mist used to promote wound healing through wound cleansing and maintenance debridement by the removal of yellow slough, fibrin, tissue exudates and bacteria.
    Device Description
    Not Found
    Ask a Question
    K Number
    K050129
    Device Name
    CELLERATION MIST THERAPY SYSTEM 5.1
    Manufacturer
    CELLERATION, INC.
    Date Cleared
    2005-05-17

    (118 days)

    Product Code
    NRB
    Regulation Number
    878.4410
    Why did this record match?
    Applicant Name (Manufacturer) :

    CELLERATION, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MIST Therapy System produces a low energy ultrasound-generated mist used to promote wound healing through wound cleansing and maintenance debridement by the removal of yellow slough, fibrin, tissue exudates and bacteria.
    Device Description
    MIST Therapy System is a non-contact, low-energy ultrasound device, which utilizes continuous ultrasonic energy to atomize saline and deliver a continuous mist to the treatment site to promote wound healing.
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    K Number
    DEN040004
    Device Name
    CELLERATION MIST THERAPY SYSTEM
    Manufacturer
    CELLERATION
    Date Cleared
    2004-06-25

    (57 days)

    Product Code
    NRB
    Regulation Number
    878.4410
    Why did this record match?
    Applicant Name (Manufacturer) :

    CELLERATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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