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

    STERITEC DRY HEAT INDICATOR LABEL

    K Number: K953122 · Decision Apr 2, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    126
    Registration Numbers
    126
    Same Product Code
    262
    Applicant Total
    19
    Review Days
    637

    Basic Information

    Device Name
    STERITEC DRY HEAT INDICATOR LABEL
    K Number
    K953122
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2800
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    STERITEC PRODUCTS MFG. CO., INC.
    Date Received
    July 5, 1995
    Decision Date
    April 2, 1997
    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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