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

    VIMEDIC SYSTEM TM

    K Number: K800163 · Decision Feb 5, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    24
    Applicant Total
    1
    Review Days
    11

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    Basic Information

    Device Name
    VIMEDIC SYSTEM TM
    K Number
    K800163
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Medical Systems Group of Viskay, Inc.
    Date Received
    January 25, 1980
    Decision Date
    February 5, 1980
    Product Code
    EFA
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EFA Handpiece, Belt And/Or Gear Driven, Dental

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