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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)
Number
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Decision
Date
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hemochron signature elite INTERNATIONAL TECHNIDYNE CORP. k050016 02/10/2005
retractofoam COLTENE/WHALEDENT AG k050013 02/09/2005
scorpio nrg knee system HOWMEDICA OSTEONICS CORP k042343 02/09/2005
hl 188 & hl 189 body fat meter HEALTH & LIFE CO., LTD. k043414 02/09/2005
c&g acupuncture needle HELIO MEDICAL SUPPLIES, INC. k043277 02/08/2005
olsen medical anterior cervical vertebrae plate system OLSEN MEDICAL k042073 02/07/2005
vitros chemistry products vanc reagent, calibrator kit 11 and tdm performance verifiers i, ii and iii Ortho-Clinical Diagnostics, Inc. k043386 02/07/2005
navigus nexdrive, model mi-3000 IMAGE-GUIDED NEUROLOGICS, INC. k043091 02/07/2005
nuvasive coroent system NUVASIVE, INC. k043405 02/07/2005
real-time position management (rpm) system EP TECHNOLOGIES, INC. k043257 02/03/2005

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