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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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Decision
Date
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dermabiosafe COMPLETE PRODUCT RESOURCES k080298 08/05/2008
centurion sorbaview otc TRI-STATE HOSPITAL SUPPLY CORP. k080524 04/23/2008
top neuropole needle, model sh, bl, sc, tc TOP CORP. k080771 11/10/2008
p.004 nc cares titanium and ceramic abutments INSTITUT STRAUMANN AG k081005 05/02/2008
21.3 inch (53cm) monochrome digital mammography lcd monitor ms51i2, (mdl2123a) TOKOTU ELECTRIC CO., LTD. k081242 06/11/2008
cfs flexible COMFORT AND FLEXIBLE SYSTEMS k081537 01/22/2009
dimension clinical chemistry system enzyme i calibrator Siemens Healthcare Diagnostics Inc. k081789 09/10/2008
avalon elite bi-caval dual lumen catheter, 13fr, 16fr, 19fr, 20fr, 23fr, 27fr, 31fr AVALON LABORATORIES, LLC k081820 10/06/2008
synthes (usa) 3.5mm lcp hook plate SYNTHES (USA) k082072 11/07/2008
mammomark, mammomark mr and cormark biopsy site identifiers ETHICON ENDO-SUGERY, LLC k082278 12/16/2008

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