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

    PROTECT DROPS/SAME AS K874070

    K Number: K874194 · Decision Dec 16, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    75
    Applicant Total
    2
    Review Days
    63

    Basic Information

    Device Name
    PROTECT DROPS/SAME AS K874070
    K Number
    K874194
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3250
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    JOHN O. BUTLER
    Date Received
    October 14, 1987
    Decision Date
    December 16, 1987
    Product Code
    EJK
    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
    EJK Liner, Cavity, Calcium Hydroxide

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