Refusal Actions by FDA as Recorded in OASIS for Czech Republic

   Manufacture Name
   City / Country or region                      District  Entry/Doc/Line/Suffix
   Product Code        Product Description
                          Date                             Reason


    Tejas, S.R.O.
    Jablonec Nad Nisoujablonec Nad Nisou , CZ 46   NYK-DO  110-0616739-5/1/1
    91D--JZ   BREATHALYZER
                        20-DEC-2007                        NOT LISTED
                                                           NO 510(K)

    Tejas, S.R.O.
    Jablonec Nad Nisoujablonec Nad Nisou , CZ 46   NYK-DO  110-0616767-6/1/1
    91D--JZ   Alcohol Breathalyzer Test
                        20-DEC-2007                        NOT LISTED
                                                           NO 510(K)

    Tejas, S.R.O.
    Jablonec Nad Nisoujablonec Nad Nisou , CZ 46   NYK-DO  110-0616848-4/1/1
    91D--JZ   Alcohol Breathalyzer Test
                        20-DEC-2007                        NOT LISTED
                                                           NO 510(K)

    Tejas, S.R.O.
    Jablonec Nad Nisoujablonec Nad Nisou , CZ 46   NYK-DO  110-0616919-3/1/1
    91D--JZ   BREATHALYZER
                        20-DEC-2007                        NOT LISTED
                                                           NO 510(K)

    Tejas, S.R.O.
    Jablonec Nad Nisoujablonec Nad Nisou , CZ 46   NYK-DO  110-0616947-4/1/1
    91D--JZ   Alcohol Breathalyzer Test
                        20-DEC-2007                        NOT LISTED
                                                           NO 510(K)

    Tejas, S.R.O.
    Jablonec Nad Nisoujablonec Nad Nisou , CZ 46   NYK-DO  110-0616958-1/1/1
    91D--JZ   Alcohol Breathalyzer Test
                        20-DEC-2007                        NOT LISTED
                                                           NO 510(K)

    Tejas, S.R.O.
    Jablonec Nad Nisoujablonec Nad Nisou , CZ 46   NYK-DO  110-0617249-4/1/1
    91D--JZ   BREATHALYZER
                        20-DEC-2007                        NOT LISTED
                                                           NO 510(K)

    Tejas, S.R.O.
    Jablonec Nad Nisoujablonec Nad Nisou , CZ 46   NYK-DO  110-0617275-9/1/1
    91D--JZ   Alcohol Breathalyzer Test
                        20-DEC-2007                        NOT LISTED
                                                           NO 510(K)

    Tejas, S.R.O.
    Jablonec Nad Nisoujablonec Nad Nisou , CZ 46   NYK-DO  110-0617321-1/1/1
    91D--JZ   Alcohol Breathalyzer Test
                        20-DEC-2007                        NOT LISTED
                                                           NO 510(K)

    Tejas, S.R.O.
    Jablonec Nad Nisoujablonec Nad Nisou , CZ 46   NYK-DO  110-0617362-5/1/1
    91D--JZ   Alcohol Breathalyzer Test
                        20-DEC-2007                        NOT LISTED
                                                           NO 510(K)

    Tejas, S.R.O.
    Jablonec Nad Nisoujablonec Nad Nisou , CZ 46   NYK-DO  110-0617378-1/1/1
    91D--JZ   Alcohol Breathalyzer Test
                        20-DEC-2007                        NOT LISTED
                                                           NO 510(K)

    Tejas, S.R.O.
    Jablonec Nad Nisoujablonec Nad Nisou , CZ 46   NYK-DO  110-0617480-5/1/1
    91D--JZ   BREATHALYZERS
                        20-DEC-2007                        NOT LISTED
                                                           NO 510(K)

    Tejas, S.R.O.
    Jablonec Nad Nisoujablonec Nad Nisou , CZ 46   NYK-DO  110-0617433-4/1/1
    91D--JZ   BREATHALYZERS
                        20-DEC-2007                        NOT LISTED
                                                           NO 510(K)

    Tejas, S.R.O.
    Jablonec Nad Nisoujablonec Nad Nisou , CZ 46   NYK-DO  110-0617463-1/1/1
    91D--JZ   Alcohol Breathalyzer Test
                        20-DEC-2007                        NOT LISTED
                                                           NO 510(K)