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

    SURESKIN SILVER BANDAGES

    K Number: K081274 · Decision May 28, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    4
    Review Days
    23

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    Basic Information

    Device Name
    SURESKIN SILVER BANDAGES
    K Number
    K081274
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Euromed, Inc.
    Date Received
    May 5, 2008
    Decision Date
    May 28, 2008
    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 Euromed, Inc.

    K Number Device Name
    K050032 EUROMED SURESKIN III WITH SILVER WOUND DRESSINGS
    K992363 SURESKIN II STANDARD, SURESKIN II BORDER, SURESKIN II THIN
    K983249 SURESKIN PLUS STANDARD, SURESKIN PLUS BORDER, SURESKIN PLUS THIN