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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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510(K)
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Decision
Date
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advance ha coated spiked tibial base and advance ha coated modular keel WRIGHT MEDICAL TECHNOLOGY, INC. k043083 04/18/2005
quest diagnostics haircheck-dt (opiates) QUEST DIAGNOSTICS, INC. k042725 07/06/2005
silimed pectoral implant SILIMED, INC. k042054 02/23/2005
hl 188 & hl 189 body fat meter HEALTH & LIFE CO., LTD. k043414 02/09/2005
femtex and private label plastic applicator tampons FIRST QUALITY HYGIENIC, INC. k050660 05/12/2005
navigus nexdrive, model mi-3000 IMAGE-GUIDED NEUROLOGICS, INC. k043091 02/07/2005
datex-ohmeda oxy-afr sensor DATEX-OHMEDA k042891 06/29/2005
aloclair oral spray SINCLAIR PHARMACEUTICALS, LTD. k042722 01/13/2005
klsa martin hand distractor KLS-MARTIN L.P. k042066 08/25/2004
safe t retractable blood collection device SAFE T MEDICAL DEVICES, LTD. k041941 09/13/2004

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