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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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dimension vista igm flex reagent cartridge and protein 1 calibrator and control l, m and h DADE BEHRING, INC. k061845 08/24/2006
prisma system r03.10a GAMBRO RENAL PRODUCTS k062090 10/18/2006
blue ptfe (fluoroplastic) ventilation tubes Grace Medical, Inc. k062385 09/27/2006
powdered vinyl patient examination gloves JIANGSU JAYSUN GLOVE CO., LTD. k062520 10/11/2006
ebi aray spinal system EBI, L.P. k062685 10/06/2006
arcomxl polyethylene liners and 38/40mm femoral heads BIOMET MANUFACTURING CORP. k062997 12/08/2006
d130 ph.i.s.i.o dideco kids neonatal arterial filter with 40 micron screen phosphorylcholine coated SORIN GROUP ITALIA S.R.L k063255 01/11/2007
accubind neo-tsh microwell elisa, model 3425-300 MONOBIND, INC. k063437 04/04/2008
lifepak 12 defibrillator/monitor MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC. k063510 01/26/2007
co2 laser system, model c-las CLINICON CORP. k063698 03/02/2007

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