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

    MONTG. TRACHEAL TREPHINE FENE STRATOR

    K Number: K802915 · Decision Dec 19, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    0
    Applicant Total
    33
    Review Days
    30

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    Basic Information

    Device Name
    MONTG. TRACHEAL TREPHINE FENE STRATOR
    K Number
    K802915
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.4420
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Boston Medical Products, Inc.
    Date Received
    November 19, 1980
    Decision Date
    December 19, 1980
    Product Code
    KBF
    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
    KBF Trephine, Sinus

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