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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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oxinium femoral heads SMITH & NEPHEW, INC. k030766 07/25/2003
auto i.d. jo-1, scl-70 & pcna positive control serum IMMUNO CONCEPTS, N.A., LTD k030775 05/12/2003
5f medtronic launcher guide catheter MEDTRONIC VASCULAR k030779 04/24/2003
newport e500 wave ventilator NEWPORT MEDICAL INSTRUMENTS, INC. k030780 01/23/2004
mega bite registration - dental bite registration material DISCUS DENTAL, INC. k030776 05/09/2003
scanlube SONOTECH, INC. k031222 07/23/2003
siemens infinity modular monitors, models sc 8000, sc 7000 and sc 9000xl, with scio SIEMENS MEDICAL SOLUTIONS USA, INC. k031340 11/25/2003
high sensitivity cortisol enzyme immunoassay SALIMETRICS LLC. k031348 06/10/2003
pvc (polyvinyl chloride) synthetic examination gloves, powdered SHANGHAI PALOMAR MOUNTAIN INDUSTRIES, INC. k992100 07/29/1999
immulite turbo intact pth, model lskptz DIAGNOSTIC PRODUCTS CORP. k992105 07/06/1999

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