BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SEPRAGEL ENT BIORESORBABLE PACKING/STENT

    K Number: K043035 · Decision Jul 11, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    32
    Applicant Total
    6
    Review Days
    250

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    Basic Information

    Device Name
    SEPRAGEL ENT BIORESORBABLE PACKING/STENT
    K Number
    K043035
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3620
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Genzyme Corporation
    Date Received
    November 3, 2004
    Decision Date
    July 11, 2005
    Product Code
    KHJ
    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
    KHJ Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)

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