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

    MDT/CASTLE MODELS S-8 TABLE TOP STEAM STERILIZER

    K Number: K910777 · Decision Mar 27, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    183
    Applicant Total
    8
    Review Days
    399

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    Basic Information

    Device Name
    MDT/CASTLE MODELS S-8 TABLE TOP STEAM STERILIZER
    K Number
    K910777
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6880
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Mdt Biologic Co.
    Date Received
    February 22, 1991
    Decision Date
    March 27, 1992
    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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    Other Clearances by Mdt Biologic Co.

    K Number Device Name
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    K943654 HARVEY CHEMICLAVE EC5000, EC5500, EC6000 STERILIZERS
    K911087 CASTLE WASHER/DISINFECTOR, MODEL 7550
    K910778 STEAM VACUUM PULSE STERILIZER SYSTEM (SVPSS)
    K910649 MDT/CASTLE 10/90 LOAD STATION
    K910942 AC POWERED AND BATTERY POWERED MEDICAL EXAM. LIGHT