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

    Non absorbable Surgical Silk Suture

    K Number: K232355 · Decision Jan 16, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    120
    Registration Numbers
    120
    Same Product Code
    40
    Applicant Total
    2
    Review Days
    162

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    Basic Information

    Device Name
    Non absorbable Surgical Silk Suture
    K Number
    K232355
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5030
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shandong Haidike Medical Product Co., Ltd.
    Date Received
    August 7, 2023
    Decision Date
    January 16, 2024
    Product Code
    GAP
    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
    GAP Suture, Nonabsorbable, Silk

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    Other Clearances by Shandong Haidike Medical Product Co., Ltd.

    K Number Device Name
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