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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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ebi optilock periarticular plating system EBI, L.P. k061098 05/24/2006
orthomon AXON SYSTEMS, INC. k061113 05/23/2006
tempfx esthetic provisional system DENTSPLY INTERNATIONAL, INC. k061264 05/23/2006
cryoshape ETGAR GROUP H.M.Y.A. LTD. k060928 05/22/2006
conmed pro2 pulse reflectance oximeter, model pro-m CONMED CORPORATION k061112 05/22/2006
zimmer trabecular metal reverse shoulder system, sizes 8mm and 10mm ZIMMER, INC. k060704 05/19/2006
tripod FREEDOM DESIGNS, INC. k060926 05/19/2006
pm-8000 express patient monitor, model pm-8000 express SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD k053193 05/18/2006
trabectome high frequency generator/lp NEOMEDIX CORP. k061258 05/18/2006
modification to arthrocare perc-d spinewand ARTHROCARE CORP. k061259 05/18/2006

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