BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇫🇷 France

    URGOCLEAN ABSORBENT WOUND DRESSING

    K Number: K123219 · Decision Mar 18, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    6
    Review Days
    154

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    Basic Information

    Device Name
    URGOCLEAN ABSORBENT WOUND DRESSING
    K Number
    K123219
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Laboratoires Urgo
    Date Received
    October 15, 2012
    Decision Date
    March 18, 2013
    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 Laboratoires Urgo

    K Number Device Name
    K143017 Urgoclean Ag, Antibacterial Absorbent Wound Dressing with Silver
    K100430 URGOTUL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER
    K100429 URGOCELL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER
    K062559 URGOCELL AG ANTIMICROBIAL WOUND DRESSING WITH SILVER
    K061220 URGOTUL AG