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

    COTTON TIPPED POINT

    K Number: K780929 · Decision Jun 30, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    364
    Registration Numbers
    364
    Same Product Code
    20
    Applicant Total
    16
    Review Days
    25

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    Basic Information

    Device Name
    COTTON TIPPED POINT
    K Number
    K780929
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6025
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Young Dental Manufacturing Co. 1, LLC
    Date Received
    June 5, 1978
    Decision Date
    June 30, 1978
    Product Code
    KXF
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KXF Applicator, Absorbent Tipped, Non-Sterile

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