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

    Silverlon Wound Contact, Burn Contact Dressings

    K Number: K190343 · Decision Jul 18, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    6
    Review Days
    154

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    Basic Information

    Device Name
    Silverlon Wound Contact, Burn Contact Dressings
    K Number
    K190343
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Argentum Medical, LLC
    Date Received
    February 14, 2019
    Decision Date
    July 18, 2019
    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 Argentum Medical, LLC

    K Number Device Name
    K241225 Silverlon® Wound Contact, Burn Contact Dressing
    K180570 Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing)
    K141033 SILVERLON ANTIMICROBIAL WOUND CONTACT NEGATIVE PRESSURE DRESSINGS, SILVERLON EASY AG ANTIMICROBIAL WOUND CONTACT NEGATIV
    K122817 SILVERLON ISLAND WOUND DRESSING
    K053590 SILVERLON CA (CALCIUM ALGINATE)