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

    ADVACOAT SINUS GEL, MODEL 9100, ADVA SINUS STENT, MODEL 9200

    K Number: K063308 · Decision Dec 4, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    106
    Registration Numbers
    106
    Same Product Code
    45
    Applicant Total
    2
    Review Days
    32

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    Basic Information

    Device Name
    ADVACOAT SINUS GEL, MODEL 9100, ADVA SINUS STENT, MODEL 9200
    K Number
    K063308
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.4780
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Carbylan Biosurgery
    Date Received
    November 2, 2006
    Decision Date
    December 4, 2006
    Product Code
    LYA
    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
    LYA Splint, Intranasal Septal

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    Other Clearances by Carbylan Biosurgery

    K Number Device Name
    K070496 ADVACOAT SINUS GEL AND STENT