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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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ohmeda inovent delivery system OHMEDA MEDICAL den000001 01/11/2000
atac pak magnesium reagent ELAN DIAGNOSTICS k030010 03/10/2003
american catheter, model w3 CATHETER LLC. k030538 03/10/2003
lasersmile BIOLASE TECHNOLOGY, INC. k030539 10/10/2003
crp-latex (ii)x2 seiken assay kit DENKA SEIKEN CO., LTD. k030545 06/02/2003
hi-torque pilot 50 guide wire with hydrocoat hydrophilic coating, hi-torque pilot 150 guide wire with hydrocoat hydrophg GUIDCORP k030549 05/14/2003
steelex electrode set AESCULAP, INC. k030556 04/22/2003
powderfree latex examination gloves with grape PT. SHAMROCK MANUFACTURING CORP. k030560 03/21/2003
ultraflex precision colonic stent BOSTON SCIENTIFIC CORP. k030769 07/14/2003
mega bite registration - dental bite registration material DISCUS DENTAL, INC. k030776 05/09/2003

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