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

    SCB/STERIS OR-LIGHT INTERFACE BOX

    K Number: K051505 · Decision Aug 11, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    93
    Registration Numbers
    93
    Same Product Code
    25
    Applicant Total
    334
    Review Days
    65

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    Basic Information

    Device Name
    SCB/STERIS OR-LIGHT INTERFACE BOX
    K Number
    K051505
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4580
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    KARL STORZ Endoscopy-America, Inc.
    Date Received
    June 7, 2005
    Decision Date
    August 11, 2005
    Product Code
    FTA
    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
    FTA Light, Surgical, Accessories

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