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

    ULTRACELL EAR WICK

    K Number: K920357 · Decision Feb 1, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    3
    Applicant Total
    24
    Review Days
    371

    Basic Information

    Device Name
    ULTRACELL EAR WICK
    K Number
    K920357
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.5220
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    ULTRACELL MEDICAL TECHNOLOGIES, INC.
    Date Received
    January 27, 1992
    Decision Date
    February 1, 1993
    Product Code
    KCN
    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
    KCN Ear Wick

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