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U.S. Department of Health and Human Services

510(K) Premarket Notification

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510(K)
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Decision
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athena multi-lyte ebv vca igm test system ZEUS SCIENTIFIC, INC. k042092 04/12/2005
0.9% sodium chloride injection, usp bd postflush sf flush syringe BECTON DICKINSON k042061 08/26/2004
10-second digital thermometer, models st87, st89, st80, st88 MESURE TECHNOLOGY CO.,LTD. k041056 05/12/2004
13c/1h occipital headcoil for magnetom allegra SIEMENS MEDICAL SOLUTIONS, INC. k042718 11/12/2004
3m littmann electronic stethoscope, model 3000 3M COMPANY k041934 10/15/2004
3viseon 3MENSIO MEDICAL IMAGING BV k043097 11/19/2004
4cis solar spine system and 4cis apollon spine system SOLCO BIOMEDICAL CO., LTD. k050471 05/12/2005
7230 ultrasound imaging system with tei BIOSOUND ESAOTE, INC. k010405 03/13/2001
8600 vital signs monitor CRITICARE SYSTEMS, INC. k042569 09/29/2004
accu-chek aviva system ROCHE DIAGNOSTICS CORP. k043474 04/27/2005

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