BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇲🇾 Malaysia

    Neuwater TM (HydrocynTM aqua)

    K Number: K142775 · Decision Feb 13, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    1
    Review Days
    140

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    Basic Information

    Device Name
    Neuwater TM (HydrocynTM aqua)
    K Number
    K142775
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Vigilenz Medical Devices
    Date Received
    September 26, 2014
    Decision Date
    February 13, 2015
    Product Code
    FRO
    Advisory Committee
    Unknown
    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
    FRO Dressing, Wound, Drug

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