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

    RAINS FRONTAL SINUS STENT

    K Number: K951066 · Decision Apr 4, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    18
    Applicant Total
    87
    Review Days
    27

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    Basic Information

    Device Name
    RAINS FRONTAL SINUS STENT
    K Number
    K951066
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Smith & Nephew Richards, Inc.
    Date Received
    March 8, 1995
    Decision Date
    April 4, 1995
    Product Code
    KAM
    Advisory Committee
    General, Plastic Surgery
    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
    KAM Cannula, Sinus

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