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

    SILVERSEAL WOUND PACKING STRIPS WITH X-STATIC

    K Number: K063190 · Decision Aug 21, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    113
    Registration Numbers
    113
    Same Product Code
    126
    Applicant Total
    5
    Review Days
    305

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    Basic Information

    Device Name
    SILVERSEAL WOUND PACKING STRIPS WITH X-STATIC
    K Number
    K063190
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Noble Fiber Technologies, Inc.
    Date Received
    October 20, 2006
    Decision Date
    August 21, 2007
    Product Code
    QSY
    Advisory Committee
    Unknown
    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
    QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics

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    Other Clearances by Noble Fiber Technologies, Inc.

    K Number Device Name
    K050726 SILVERSEAL SILVERAID WITH X-STATIC
    K051256 SILVERSEAL ORTHOTIC COMPONENT WITH X-STATIC
    K050649 SILVERSEAL CONTACTING WOUND DRESSING WITH X-STATIC
    K043526 SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC