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

    Ultra Silver Dressings

    K Number: K141603 · Decision Oct 22, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    3
    Review Days
    128

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    Basic Information

    Device Name
    Ultra Silver Dressings
    K Number
    K141603
    Device Class
    FDA unclassified
    Clearance Type
    Special
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Milliken Healthcare Products, LLC
    Date Received
    June 16, 2014
    Decision Date
    October 22, 2014
    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 Milliken Healthcare Products, LLC

    K Number Device Name
    K110715 INTERDRY SILVER
    K103141 LOW ADHERENT AFM AG DRESSINGS