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

    Hydrofera Blue READY - Border

    K Number: K190268 · Decision Nov 6, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    7
    Review Days
    271

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    Basic Information

    Device Name
    Hydrofera Blue READY - Border
    K Number
    K190268
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hydrofera, LLC
    Date Received
    February 8, 2019
    Decision Date
    November 6, 2019
    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
    K130670 HYDROFERA BLUE PU BACTERIOSTATIC DRESSING
    K023138 HYDROFERA BACTERIOSTATIC WOUND DRESSING
    K013462 HYDROFERA BACTERIOSTATIC WOUND DRESSING
    K983276 HYDROFERA BACTERISTATIC NASAL DRESSING
    K974313 HYDROFERA SURGICAL SPEAR
    K974316 HYDROFERA FEMORAL WICK