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

    STERITEC GREEN CARD PACK BOWIE-DICK TEST MODEL BD 126

    K Number: K122945 · Decision Apr 30, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    264
    Applicant Total
    22
    Review Days
    218

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    Basic Information

    Device Name
    STERITEC GREEN CARD PACK BOWIE-DICK TEST MODEL BD 126
    K Number
    K122945
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    880.2800
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Steritec Products Mfg Co, Inc.
    Date Received
    September 24, 2012
    Decision Date
    April 30, 2013
    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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