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U.S. Department of Health and Human Services

510(K) Premarket Notification
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Device Name
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Applicant
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510(K)
Number
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Decision
Date
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colormate tlc bilitest system CHROMATICS COLOR SCIENCES INTL., INC. k001687 09/13/2001
combison 301 pw ultrasound system and transducers MEDISON CO., LTD. k002491 08/25/2000
comfor-cliner RECLINER CARE, INC. k010194 02/15/2001
components for cardiovascular procedure kit - heat exchanger coils OLSON MEDICAL SALES, INC. k000977 03/23/2001
compumedics e-series eeg system COMPUMEDICS NEURO SCIENCE PTY LTD. k000068 03/13/2000
concentroc hd guide catheter, models 90017 (4f), 90019 (5f), 90021 (6f), 90022 (7f), 90023 (8f), 90024 (9f) CONCENTRIC MEDICAL, INC. k003880 05/16/2001
conductive gel for ultrasound SKYLARK DEVICE & SYSTEMS CO., LTD k002832 08/06/2001
continuum knee system-ps femoral components- porous, model xx-yyy-zzzzz IMPLEX CORP. k001307 05/23/2000
cool-tec electrodes SEEDLING ENTERPRISES. LLC. k002841 12/08/2000
cordis trapease permanent vena cava filter and introduction kit CORDIS CORP. k000062 07/07/2000

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