BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇬🇧 United Kingdom

    SILVER ALGINATE 11 WOUND DRESSING

    K Number: K090453 · Decision Feb 26, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    11
    Review Days
    3

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    Basic Information

    Device Name
    SILVER ALGINATE 11 WOUND DRESSING
    K Number
    K090453
    Device Class
    FDA unclassified
    Clearance Type
    Special
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Advanced Medical Solutions Limited
    Date Received
    February 23, 2009
    Decision Date
    February 26, 2009
    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 Advanced Medical Solutions Limited

    K Number Device Name
    K223310 Antimicrobial Silicone PHMB Foam Wound Dressing
    K211878 LiquiBand XL
    K183570 LiquiBand Plus
    K110458 SILVER ANTIMICROBIAL WOUND GEL
    K091013 SILVER PU ANTIBACTERIAL FOAM DRESSING - NON ADHERENT AND ISLAND
    K080503 SILVER ALGINATE IV ANTIMICROBIAL WOUND DRESSING
    K081363 NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING, SILVERCEL NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING
    K073197 SILVER ANTIMICROBIAL WOUND GEL
    K070581 SILVER ALGINATE II WOUND DRESSING
    K063173 MODIFICATION TO SILVER ALGINATE II WOUND DRESSING
    Search all 11 clearances from Advanced Medical Solutions Limited →