BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    HYDROFERA BACTERISTATIC NASAL DRESSING

    K Number: K983276 · Decision Sep 14, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    60
    Registration Numbers
    60
    Same Product Code
    46
    Applicant Total
    7
    Review Days
    362

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    Basic Information

    Device Name
    HYDROFERA BACTERISTATIC NASAL DRESSING
    K Number
    K983276
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.4100
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Hydrofera, LLC
    Date Received
    September 17, 1998
    Decision Date
    September 14, 1999
    Product Code
    EMX
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EMX Balloon, Epistaxis

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    Other Clearances by Hydrofera, LLC

    K Number Device Name
    K190268 Hydrofera Blue READY - Border
    K130670 HYDROFERA BLUE PU BACTERIOSTATIC DRESSING
    K023138 HYDROFERA BACTERIOSTATIC WOUND DRESSING
    K013462 HYDROFERA BACTERIOSTATIC WOUND DRESSING
    K974313 HYDROFERA SURGICAL SPEAR
    K974316 HYDROFERA FEMORAL WICK