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

    SILVERSEAL CONTACTING WOUND DRESSING WITH X-STATIC

    K Number: K050649 · Decision Jun 13, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    5
    Review Days
    91

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    Basic Information

    Device Name
    SILVERSEAL CONTACTING WOUND DRESSING WITH X-STATIC
    K Number
    K050649
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Noble Fiber Technologies, Inc.
    Date Received
    March 14, 2005
    Decision Date
    June 13, 2005
    Product Code
    FRO
    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
    FRO Dressing, Wound, Drug

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    Other Clearances by Noble Fiber Technologies, Inc.

    K Number Device Name
    K063190 SILVERSEAL WOUND PACKING STRIPS WITH X-STATIC
    K050726 SILVERSEAL SILVERAID WITH X-STATIC
    K051256 SILVERSEAL ORTHOTIC COMPONENT WITH X-STATIC
    K043526 SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC