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U.S. Department of Health and Human Services

510(K) Premarket Notification
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510(K)
Number
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Decision
Date
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litho laser system QUANTA SYSTEM, S.P.A. k091909 07/09/2009
reprocessed electrophysiology diagnostic catheters STERILMED, INC. k092158 01/14/2010
maia, model 1 CENTERVUE SPA k092187 05/27/2010
sdx-spirodynr'x radiotherapy breathing control DYN'R k092479 01/11/2010
spectre wireless encrypted footswitch and hand switch system TRANSAMERICAN MEDICAL IMAGING k092713 07/16/2010
dana reusable test pack for steam sterilization DANA PRODUCTS, INC. k092944 03/18/2010
coagusense self-test prothrombin time/inr monitoring system COAGUSENSE, INC k093243 04/07/2010
pinpointe footlaser model 6w, 30w, 100w INCISIVE, INC. (FORMERLY NAMED INCISIVE, LLC) k093545 10/15/2010
i.t.s. lrs locking reconstruction system I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH k093868 08/05/2010
denfil etchant-37 VERICOM CO., LTD. k080265 02/06/2008

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