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U.S. Department of Health and Human Services

510(K) Premarket Notification

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510(K)
Number
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Decision
Date
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acis (automated cellular imaging system) CHROMA VISION MEDICAL SYSTEMS INC. k032113 12/23/2003
sequoia 8.0 diagnostic ultrasound system SIEMENS MEDICAL SOLUTIONS USA, INC. k032114 07/21/2003
neurolac nerve guide models ng01-15/03, ng01-020/03, ng01 025/03, ng01-030/03 Polyganics BV k032115 10/10/2003
tulip colorswitch CAVEX HOLLAND B.V. k032116 09/30/2003
stryker total performance (tps) system STRYKER INSTRUMENTS k032117 08/08/2003
paragon medical surgical instrument delivery system various PARAGON MEDICAL, INC. k032119 10/29/2003
modification to e-scan xq ESAOTE S.P.A. k032121 08/13/2003
audit microcontrols microfd bnp control AALTO SCIENTIFIC LTD. k032122 09/09/2003
shockwave suspension wheelchair PER4MAX MEDICAL, LLC k032123 07/31/2003
durex play lubricant SSL AMERICAS, INC. k032124 01/16/2004

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