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

    RUTTER SUPRA STOMAL STENTS

    K Number: K091135 · Decision Sep 14, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    9
    Applicant Total
    33
    Review Days
    147

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    Basic Information

    Device Name
    RUTTER SUPRA STOMAL STENTS
    K Number
    K091135
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3620
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Boston Medical Products, Inc.
    Date Received
    April 20, 2009
    Decision Date
    September 14, 2009
    Product Code
    FWN
    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
    FWN Prosthesis, Larynx (Stents And Keels)

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