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

    CASTLE MODEL 233HC STEAM STERILIZER

    K Number: K003441 · Decision Jan 2, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    183
    Applicant Total
    9
    Review Days
    57

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    Basic Information

    Device Name
    CASTLE MODEL 233HC STEAM STERILIZER
    K Number
    K003441
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.6880
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Getinge/Castle, Inc.
    Date Received
    November 6, 2000
    Decision Date
    January 2, 2001
    Product Code
    FLE
    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
    FLE Sterilizer, Steam

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