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

    UC-CARE WARMING SYSTEM

    K Number: K090978 · Decision Aug 10, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    261
    Applicant Total
    5
    Review Days
    126

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    Basic Information

    Device Name
    UC-CARE WARMING SYSTEM
    K Number
    K090978
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4350
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    UC-CARE , Ltd.
    Date Received
    April 6, 2009
    Decision Date
    August 10, 2009
    Product Code
    GEH
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GEH Unit, Cryosurgical, Accessories

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    Other Clearances by UC-CARE , Ltd.

    K Number Device Name
    K250664 Navigo Workstation 2.3 (FPRMC00039)
    K173054 Navigo Workstation Version 2.0
    K160934 UC-CARE NaviGo Workstation
    K100784 UC-CARE NAVIGO SYTEM