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

    BUTLER G.U.M. ANTIBACTERIAL TOOTHBRUSH

    K Number: K950993 · Decision Jun 2, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    573
    Registration Numbers
    574
    Same Product Code
    48
    Applicant Total
    2
    Review Days
    91

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    Basic Information

    Device Name
    BUTLER G.U.M. ANTIBACTERIAL TOOTHBRUSH
    K Number
    K950993
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6855
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    John O. Butler
    Date Received
    March 3, 1995
    Decision Date
    June 2, 1995
    Product Code
    EFW
    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
    EFW Toothbrush, Manual

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    Other Clearances by John O. Butler

    K Number Device Name
    K874194 PROTECT DROPS/SAME AS K874070