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

    Sterilization Wrap

    K Number: K223600 · Decision Aug 25, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    194
    Registration Numbers
    194
    Same Product Code
    321
    Applicant Total
    6
    Review Days
    266

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    Basic Information

    Device Name
    Sterilization Wrap
    K Number
    K223600
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wuhan Zonsen Medical Products Co., Ltd.
    Date Received
    December 2, 2022
    Decision Date
    August 25, 2023
    Product Code
    FRG
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FRG Wrap, Sterilization

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