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

    MODIFICATION TO SILVER ALGINATE II WOUND DRESSING

    K Number: K063173 · Decision Nov 3, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    11
    Review Days
    15

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    Basic Information

    Device Name
    MODIFICATION TO SILVER ALGINATE II WOUND DRESSING
    K Number
    K063173
    Device Class
    FDA unclassified
    Clearance Type
    Special
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Advanced Medical Solutions Limited
    Date Received
    October 19, 2006
    Decision Date
    November 3, 2006
    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

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    K091013 SILVER PU ANTIBACTERIAL FOAM DRESSING - NON ADHERENT AND ISLAND
    K090453 SILVER ALGINATE 11 WOUND DRESSING
    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
    Search all 11 clearances from Advanced Medical Solutions Limited →