BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Innomed NPWT Silicone Foam Dressing

    K Number: K202823 · Decision Dec 15, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    105
    Registration Numbers
    105
    Same Product Code
    211
    Applicant Total
    4
    Review Days
    447

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    Basic Information

    Device Name
    Innomed NPWT Silicone Foam Dressing
    K Number
    K202823
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4780
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zhejiang Longterm Medical Technology Co., Ltd.
    Date Received
    September 24, 2020
    Decision Date
    December 15, 2021
    Product Code
    OMP
    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
    OMP Negative Pressure Wound Therapy Powered Suction Pump

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    Other Clearances by Zhejiang Longterm Medical Technology Co., Ltd.

    K Number Device Name
    K211571 Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit
    K192478 LT Antibacterial Alginate with Silver Dressing
    K182458 Longterm NPWT Foam Dressing Kit