Refusal Actions by FDA as Recorded in OASIS for Austria

   Manufacture Name
   City / Country or region                      District  Entry/Doc/Line/Suffix
   Product Code        Product Description
                          Date                             Reason
Die Kasemacher Thaya , AT FLA-DO MC2-6037781-7/1/1A 12BCE08 CHEESE AND SWEET PEPPERS IN OLIVE OIL 13-JUN-2008 NEEDS FCE NO PROCESS Die Kasemacher Thaya , AT FLA-DO MC2-6037781-7/1/1B 12BCE08 CHEESE AND YELLOWBELL SQUASH IN OLIVE OIL 13-JUN-2008 NEEDS FCE NO PROCESS Die Kasemacher Thaya , AT FLA-DO MC2-6037781-7/2/1 21GCE12 OLIVES STUFFED WITH CHEESE IN OIL 13-JUN-2008 NEEDS FCE NO PROCESS Die Kasemacher Thaya , AT FLA-DO MC2-6037781-7/3/1 12BCE08 CHAMPIGNON MUSHROOMS STUFFED W/CHEESE IN VEG. OIL & HERBS 13-JUN-2008 NEEDS FCE NO PROCESS Die Kasemacher Thaya , AT FLA-DO MC2-6037781-7/4/1 12BCE08 ONIONS STUFFED W/FRESH CHEESE IN VEG. OIL & HERBS 13-JUN-2008 NEEDS FCE NO PROCESS Zotter Schokoladen Manufaktur Gmbh Bergl , AT NOL-DO 112-2894632-6/1/1 34KFT04 790507803967 CHOCOLATES 23-JUN-2008 NUTRIT LBL Hermann Pfanner Getraenke Ges.m.b.H. Lauterach AT-4, AT 6923 DET-DO 144-1016109-8/1/1 31KGO20 Green Tea with Lemon and Prickly Pear 26-JUN-2008 LABELING NUTRIT LBL Hermann Pfanner Getraenke Ges.m.b.H. Lauterach AT-4, AT 6923 DET-DO 144-1016109-8/2/1 29AGO03 Green Apple Cocktail Drink 26-JUN-2008 UNSAFE COL COLOR LBLG LABELING NUTRIT LBL W & H DentalWerk Buermoos GMBH Burmoos SBG, AT 5111 LOS-DO 336-6589782-6/1/1 76E--IF NB-OSSEOSET 200 SI-915 30-JUN-2008 NOT LISTED NO 510(K) W & H DentalWerk Buermoos GMBH Burmoos SBG, AT 5111 LOS-DO 336-6589782-6/1/2 76E--IF WI-75 E/KM CONTRA-ANGLE 30-JUN-2008 NOT LISTED NO 510(K) W & H DentalWerk Buermoos GMBH Burmoos SBG, AT 5111 LOS-DO 336-6589782-6/2/1 76E--IF MOTOR WITH MOUNTED CONNECTION CABLE. 30-JUN-2008 NOT LISTED NO 510(K) W & H DentalWerk Buermoos GMBH Burmoos SBG, AT 5111 LOS-DO 336-6589782-6/2/2 76E--IF MOTOR WITH MOUNTED CONNECTION CABLE 30-JUN-2008 NOT LISTED NO 510(K) W & H DentalWerk Buermoos GMBH Burmoos SBG, AT 5111 LOS-DO 336-6589782-6/4/1 76E--IF WI-75 E/KM CONTRA-ANGLE 30-JUN-2008 NOT LISTED NO 510(K) W & H DentalWerk Buermoos GMBH Burmoos SBG, AT 5111 LOS-DO 336-6589782-6/4/2 76E--IF NB-OSSEOSET 200 SI-915 30-JUN-2008 NOT LISTED NO 510(K) W & H DentalWerk Buermoos GMBH Burmoos SBG, AT 5111 LOS-DO 336-6589782-6/6/1 76E--IF SPRAY TUBE,ACCESSORY. 30-JUN-2008 NOT LISTED NO 510(K) W & H DentalWerk Buermoos GMBH Burmoos SBG, AT 5111 LOS-DO 336-6590005-9/1/1 76E--IF OSSEOSET 30-JUN-2008 REGISTERED NO 510(K) W & H DentalWerk Buermoos GMBH Burmoos SBG, AT 5111 LOS-DO 336-6590005-9/1/2 76E--IF WI-75 E/KM SURGIGCAL CONTRA-ANGLE.UR 30-JUN-2008 REGISTERED NO 510(K) W & H DentalWerk Buermoos GMBH Burmoos SBG, AT 5111 LOS-DO 336-6590005-9/1/3 76E--IF WI-75 E/KM SURGIGCAL CONTRA-ANGLE. 30-JUN-2008 REGISTERED NO 510(K) W & H DentalWerk Buermoos GMBH Burmoos SBG, AT 5111 LOS-DO 336-6590005-9/1/4 76E--IF OSSEOSET 30-JUN-2008 REGISTERED NO 510(K) W & H DentalWerk Buermoos GMBH Burmoos SBG, AT 5111 LOS-DO 336-6590005-9/2/1 76E--IF MOTOR WITH CABLE. 30-JUN-2008 REGISTERED NO 510(K) W & H DentalWerk Buermoos GMBH Burmoos SBG, AT 5111 LOS-DO 336-6590005-9/2/2 76E--IF MOTOR WITH MOUNTED CONNECTION CABLE. 30-JUN-2008 REGISTERED NO 510(K) W & H DentalWerk Buermoos GMBH Burmoos SBG, AT 5111 LOS-DO 336-6590005-9/3/1 76E--IF SURGICAL HANDPIECE SHORT 30-JUN-2008 REGISTERED NO 510(K) W & H DentalWerk Buermoos GMBH Burmoos SBG, AT 5111 LOS-DO 336-6590005-9/3/2 76E--IF SPRAY TUBE CPL, ACCESSORY 30-JUN-2008 REGISTERED NO 510(K) W & H DentalWerk Buermoos GMBH Burmoos SBG, AT 5111 LOS-DO 336-6590005-9/3/3 76E--IF WI-75 E/KM SURGIGCAL CONTRA-ANGLE.UR 30-JUN-2008 REGISTERED NO 510(K)