BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Steam-Dot Process Indicator

    K Number: K210553 · Decision May 19, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    264
    Applicant Total
    7
    Review Days
    83

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    Basic Information

    Device Name
    Steam-Dot Process Indicator
    K Number
    K210553
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    880.2800
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Propper Manufacturing Co., Inc.
    Date Received
    February 25, 2021
    Decision Date
    May 19, 2021
    Product Code
    JOJ
    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
    JOJ Indicator, Physical/Chemical Sterilization Process

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