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

    HYDROFERA BLUE PU BACTERIOSTATIC DRESSING

    K Number: K130670 · Decision Jan 2, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    7
    Review Days
    296

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    Basic Information

    Device Name
    HYDROFERA BLUE PU BACTERIOSTATIC DRESSING
    K Number
    K130670
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hydrofera, LLC
    Date Received
    March 12, 2013
    Decision Date
    January 2, 2014
    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 Hydrofera, LLC

    K Number Device Name
    K190268 Hydrofera Blue READY - Border
    K023138 HYDROFERA BACTERIOSTATIC WOUND DRESSING
    K013462 HYDROFERA BACTERIOSTATIC WOUND DRESSING
    K983276 HYDROFERA BACTERISTATIC NASAL DRESSING
    K974313 HYDROFERA SURGICAL SPEAR
    K974316 HYDROFERA FEMORAL WICK