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

    Self Sealing Sterilization Pouches

    K Number: K243721 · Decision Apr 25, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    203
    Registration Numbers
    203
    Same Product Code
    316
    Applicant Total
    2
    Review Days
    143

    Basic Information

    Device Name
    Self Sealing Sterilization Pouches
    K Number
    K243721
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Wellmed Dental Medical Supply Co., Ltd
    Date Received
    December 3, 2024
    Decision Date
    April 25, 2025
    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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