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

    SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC

    K Number: K043526 · Decision Mar 10, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    30
    Applicant Total
    5
    Review Days
    79

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    Basic Information

    Device Name
    SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC
    K Number
    K043526
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.5940
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Noble Fiber Technologies, Inc.
    Date Received
    December 21, 2004
    Decision Date
    March 10, 2005
    Product Code
    LGF
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LGF Component, Cast

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