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

    dermaPACE System

    K Number: DEN160037 · Decision Dec 28, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    521

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    Basic Information

    Device Name
    dermaPACE System
    K Number
    DEN160037
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    878.4685
    Medical Specialty
    General, Plastic Surgery
    Decision
    Unknown
    Applicant
    Sanuwave, Inc.
    Date Received
    July 25, 2016
    Decision Date
    December 28, 2017
    Product Code
    PZL
    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
    PZL Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers

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