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

    3MM DISPOSABLE SPECULA

    K Number: K891589 · Decision Apr 18, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    29

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    Basic Information

    Device Name
    3MM DISPOSABLE SPECULA
    K Number
    K891589
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.1800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Semantodontics, Inc.
    Date Received
    March 20, 1989
    Decision Date
    April 18, 1989
    Product Code
    FXG
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FXG Specula Accessories