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

    GENTAL PULSE

    K Number: K950238 · Decision May 9, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    21
    Applicant Total
    45
    Review Days
    109

    Basic Information

    Device Name
    GENTAL PULSE
    K Number
    K950238
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.1720
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    PARKELL, INC.
    Date Received
    January 20, 1995
    Decision Date
    May 9, 1995
    Product Code
    EAT
    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
    EAT Tester, Pulp

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