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

    SHEA MIDDLE EAR MICRODRILL

    K Number: K833874 · Decision Jun 22, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    90
    Applicant Total
    2
    Review Days
    227

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    Basic Information

    Device Name
    SHEA MIDDLE EAR MICRODRILL
    K Number
    K833874
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4250
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Applied Research Corp.
    Date Received
    November 8, 1983
    Decision Date
    June 22, 1984
    Product Code
    ERL
    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
    ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

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    Other Clearances by Applied Research Corp.

    K Number Device Name
    K833875 SHEA FOOTPLATE MICRODRILL