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

    INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMS

    K Number: K051157 · Decision Sep 1, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    266
    Registration Numbers
    266
    Same Product Code
    279
    Applicant Total
    29
    Review Days
    119

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    Basic Information

    Device Name
    INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMS
    K Number
    K051157
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Micromedics, Inc.
    Date Received
    May 5, 2005
    Decision Date
    September 1, 2005
    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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