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U.S. Department of Health and Human Services

510(K) Premarket Notification

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global advantage extended humeral head DEPUY ORTHOPAEDICS, INC. k000575 03/10/2000
elecsys cortisol calcheck ROCHE DIAGNOSTICS CORP. k000576 03/21/2000
yoshida wave pict cam intraoral camera, sigma biomedics sigmacam intraoral camera THE YOSHIDA DENTAL MFG. CO., LTD. k000577 05/05/2000
serim leukocyte esterase test strips SERIM RESEARCH CORP. k000578 05/05/2000
tempo aqua angiographic catheter CORDIS CORP. k000579 05/03/2000
zurich pediatric maxillary distractor, models 51-550-15 and 51-551-15 KLS-MARTIN L.P. k000580 07/24/2000
maeda new needle disposable MAEDA TOYOKICHI SHOTEN k000581 02/23/2001
freestyle blood glucose monitoring system, cat no 11001 ABBOTT DIABETES CARE INC. k000582 12/05/2000
fasttake compact blood glucose monitoring system SELFCARE, INC. k000583 03/17/2000
powder-free latex examination gloves with protein content labeling claim (50 micrograms or less) SHASTA ASIA PARTNERS GLOVES MANUFACTURING CO LTD. k000584 04/12/2000

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