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    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    SORING MBC200/BCC140

    K Number: K093511 · Decision Apr 16, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    7
    Review Days
    154

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    Basic Information

    Device Name
    SORING MBC200/BCC140
    K Number
    K093511
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Soring GmbH Medizintechnik
    Date Received
    November 13, 2009
    Decision Date
    April 16, 2010
    Product Code
    GEI
    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
    GEI Electrosurgical, Cutting & Coagulation & Accessories

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    Other Clearances by Soring GmbH Medizintechnik

    K Number Device Name
    K052183 SORING GMBH SONOCA LIPO
    K030028 CPC BY SORING GMBH
    K024059 MBC SERIES
    K012753 SORING GMBH SONOCA 180/190
    K993265 SORING GMBH, ARCO 3000, ARCO 2000, ARCO 1000, MBC 601, MBC 600
    K992026 SORING GMBH, SONOCA 300