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

    SURGICAL DRILL-ELECTRIC-HANDPIECE

    K Number: K831946 · Decision Nov 3, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    90
    Applicant Total
    2
    Review Days
    140

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    Basic Information

    Device Name
    SURGICAL DRILL-ELECTRIC-HANDPIECE
    K Number
    K831946
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4250
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Entronics
    Date Received
    June 16, 1983
    Decision Date
    November 3, 1983
    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 Entronics

    K Number Device Name
    K862989 SURGICAL DRILL (ELECTRIC) INCLUDING HANDPIECE