BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    SALUS - Hygiene Instrument Reprocessing Container

    K Number: K172292 · Decision Nov 24, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    266
    Registration Numbers
    266
    Same Product Code
    279
    Applicant Total
    11
    Review Days
    116

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    Basic Information

    Device Name
    SALUS - Hygiene Instrument Reprocessing Container
    K Number
    K172292
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Scican , Ltd.
    Date Received
    July 31, 2017
    Decision Date
    November 24, 2017
    Product Code
    KCT
    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
    KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

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