BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SLIVASURE

    K Number: K051409 · Decision Aug 8, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    15
    Applicant Total
    1
    Review Days
    69

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    Basic Information

    Device Name
    SLIVASURE
    K Number
    K051409
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.1850
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Scandinavian Formulas, Inc.
    Date Received
    May 31, 2005
    Decision Date
    August 8, 2005
    Product Code
    LED
    Advisory Committee
    Hematology
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LED Stains, Chemical Solution

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