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

    Self Sealing Sterilization Pouches

    K Number: K162258 · Decision Apr 28, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    194
    Registration Numbers
    194
    Same Product Code
    321
    Applicant Total
    2
    Review Days
    260

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    Basic Information

    Device Name
    Self Sealing Sterilization Pouches
    K Number
    K162258
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tianchang Jiarui Packaging Material Co., Ltd.
    Date Received
    August 11, 2016
    Decision Date
    April 28, 2017
    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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    Other Clearances by Tianchang Jiarui Packaging Material Co., Ltd.

    K Number Device Name
    K181957 Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization Pouch Gusseted, Heat Sealing Sterilization Pouch Roll Flat, Heat Sealing Sterilization Pouch Roll Gusseted