BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇨🇳 China

    SURECELL Gelling Fiber Wound Dressing

    K Number: K173005 · Decision May 25, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    134
    Registration Numbers
    134
    Same Product Code
    187
    Applicant Total
    1
    Review Days
    240

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    Basic Information

    Device Name
    SURECELL Gelling Fiber Wound Dressing
    K Number
    K173005
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jiangsu Newvalue Medical Producst Co.,Ltd
    Date Received
    September 27, 2017
    Decision Date
    May 25, 2018
    Product Code
    KGN
    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
    KGN Wound Dressing With Animal-Derived Material(S)

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