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

    MEPILEX BORDER AG DRESSING

    K Number: K100029 · Decision Sep 15, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    9
    Review Days
    252

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    Basic Information

    Device Name
    MEPILEX BORDER AG DRESSING
    K Number
    K100029
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Molnlycke Health Care
    Date Received
    January 6, 2010
    Decision Date
    September 15, 2010
    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 Molnlycke Health Care

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    K102923 BARRIER N95 PARTICULATE RESPIRATOR
    K061554 MEPILEX AG ABSORBENT SILICONE-COATED DRESSING
    K050786 BARRIER SURGICAL GOWNS
    K031131 KLINIDRAPE SURGICAL DRAPES