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

    MDT/CASTLE 10/90 DUAL LOAD STATION

    K Number: K920930 · Decision Mar 31, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    25
    Applicant Total
    22
    Review Days
    397

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    Basic Information

    Device Name
    MDT/CASTLE 10/90 DUAL LOAD STATION
    K Number
    K920930
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mdt Corp., Inc.
    Date Received
    February 28, 1992
    Decision Date
    March 31, 1993
    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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