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

    UNIDRIVE II PLUS DISPOSABLE TUBING SET

    K Number: K021811 · Decision Jun 19, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    90
    Applicant Total
    10
    Review Days
    16

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    Basic Information

    Device Name
    UNIDRIVE II PLUS DISPOSABLE TUBING SET
    K Number
    K021811
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4250
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mtp Medical Technical Promotion GmbH
    Date Received
    June 3, 2002
    Decision Date
    June 19, 2002
    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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