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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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geratherm babywatch temperature monitor GERATHERM AG k001281 06/12/2001
multi-stim, model ms-100 METRON MEDICAL AUSTRALIA PTY LTD k001897 06/12/2001
uss-line extension SYNTHES k010108 06/06/2001
infant limb holder, models 306080 & 306081 SKIL-CARE CORP. k010818 05/24/2001
gem posterior stabilized total knee system KINAMED, INC. k010101 05/17/2001
lifelines trackit LIFELINES LTD. k010460 05/14/2001
dento-prep particle microblaster RONVIG A/S k010816 05/10/2001
acti-gard antimicrobial film, models d6635, d6640, d6648, d6650,d6651, d66xx MEDICAL CONCEPTS DEVELOPMENT, INC. k000442 04/24/2001
reflex anterior cervical plate system HOWMEDICA OSTEONICS CORP. k010115 04/16/2001
emit 2000 carbamazepine assay, model osr4f229 SYVA CO., DADE BEHRING, INC. k010814 04/13/2001

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