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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
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passeo 18 BIOTRONIK, INC. k072765 12/12/2007
depuy pinnacle altrx acetabular liners DEPUY ORTHOPAEDICS, INC. k072963 01/09/2008
vitalograph model 4000 (asma-1 and copd-6) VITALOGRAPH(IRELAND) LTD. k073155 06/04/2008
therabond antimicrobial barrier systems CHOICE THERAPEUTICS k073213 05/28/2008
nemus system; nemus pc peripheral EB NEURO, S.P.A. k073415 05/23/2008
pharaon lipo OSYRIS k073617 04/09/2008
cobas integra chloride elctrode gen.2 ROCHE DIAGNOSTICS CORP. k060108 02/16/2006
spiralok anchor DEPUY MITEK, A JOHNSON & JOHNSON COMPANY k060271 05/04/2006
digital radiography cxdi-50c CANON INC. k060433 03/10/2006
ortho development ceramic femoral heads ORTHO DEVELOPMENT CORP. k060577 04/28/2006

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