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

    ARGLAES-AB ANTIMICROBIAL BARRIER FILM DRESSING & ISLAND DRESSING

    K Number: K990810 · Decision Sep 17, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    4
    Review Days
    190

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    Basic Information

    Device Name
    ARGLAES-AB ANTIMICROBIAL BARRIER FILM DRESSING & ISLAND DRESSING
    K Number
    K990810
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Maersk Medical, Ltd.
    Date Received
    March 11, 1999
    Decision Date
    September 17, 1999
    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 Maersk Medical, Ltd.

    K Number Device Name
    K004028 ARGLAES-AB ANTIMICROBIAL BARRIER POWDER DRESSING
    K973657 ARGLAES-AB ANTIMICROBIAL BARRIER ISLAND DRESSING
    K970566 ARGLAES FILM DRESSING