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U.S. Department of Health and Human Services

510(K) Premarket Notification
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510(K)
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idrive system (i drive power handle, idrive (ralc) single use reload) COVIDIEN LLC, FORMERLY REGISTERED AS TYCO HEALTHCA k102325 10/13/2010
vitek 2 yeast caspofungin BIOMERIEUX, INC. k101566 09/28/2010
trans1 lateral intervertebral fusion device, t TRANS1 INCORPORATED k100210 08/26/2010
shimadzu collimator r-20j SHIMADZU CORP. k101036 08/26/2010
pediatric body-cardiac coil, model: 5000012601 SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD k101949 07/28/2010
powdered vinyl patient examination gloves SHIJIAZHUANG STAR PLASTIC CO., LTD k101343 07/16/2010
colored powder free and polymer coated examination glove (blue, black and pink) with a protein claim of less than TEKMEDIC (M) SDN BHD k100694 06/25/2010
simpler toadstool abutment, model s19000-s19009 PAN GLOBAL IMPLANT k093975 06/04/2010
vinyl examination glove, powder free, non-colored QINGDAO LANG HUI IMPORT & EXPORT CO., LTD k093264 05/28/2010
systems integration model: endoalpha OLYMPUS MEDICAL SYSTEMS CORPORATION k100345 03/22/2010

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