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

    PROPPER EO LINE ETHYLENE OXIDE STERILIZATION INTEGRATOR

    K Number: K973585 · Decision Nov 6, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    264
    Applicant Total
    25
    Review Days
    410

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    Basic Information

    Device Name
    PROPPER EO LINE ETHYLENE OXIDE STERILIZATION INTEGRATOR
    K Number
    K973585
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2800
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Propper Mfg. Co., Inc.
    Date Received
    September 22, 1997
    Decision Date
    November 6, 1998
    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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