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

    Non Absorbable Surgical Nylon Suture

    K Number: K212603 · Decision Dec 22, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    56
    Applicant Total
    2
    Review Days
    127

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    Basic Information

    Device Name
    Non Absorbable Surgical Nylon Suture
    K Number
    K212603
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5020
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shandong Haidike Medical Product Co., Ltd.
    Date Received
    August 17, 2021
    Decision Date
    December 22, 2021
    Product Code
    GAR
    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
    GAR Suture, Nonabsorbable, Synthetic, Polyamide

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

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