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

    MDT/CASTLE 10/90 LOAD STATION

    K Number: K910649 · Decision Sep 6, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    25
    Applicant Total
    8
    Review Days
    204

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    Basic Information

    Device Name
    MDT/CASTLE 10/90 LOAD STATION
    K Number
    K910649
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Mdt Biologic Co.
    Date Received
    February 14, 1991
    Decision Date
    September 6, 1991
    Product Code
    FLF
    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
    FLF Sterilizer, Ethylene-Oxide Gas

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    Other Clearances by Mdt Biologic Co.

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    K954736 ACCESS (POWERCLAVE)
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    K943654 HARVEY CHEMICLAVE EC5000, EC5500, EC6000 STERILIZERS
    K911087 CASTLE WASHER/DISINFECTOR, MODEL 7550
    K910777 MDT/CASTLE MODELS S-8 TABLE TOP STEAM STERILIZER
    K910778 STEAM VACUUM PULSE STERILIZER SYSTEM (SVPSS)
    K910942 AC POWERED AND BATTERY POWERED MEDICAL EXAM. LIGHT