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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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spife ld-12 kit, model 3338 HELENA LABORATORIES k022455 10/01/2002
audiotraveller, model aa222 INTERACOUSTICS A/S, ASSENS k022728 10/11/2002
vinyl examination gloves, pre-powdered SHANDONG JIAZHAN PLASTIC PRODUCTS CO., LTD. k023145 10/11/2002
aeu-425 transport ii portable dental system ASEPTICO, INC. k022217 10/24/2002
medisense precision pcx point of care management system for blood glucose testing ABBOTT LABORATORIES k022941 10/28/2002
gyneflex NAISSANCE HOLDINGS, LC k021115 12/20/2002
seraquest anti-thyroglobulin QUEST INTL., INC. k023592 01/06/2003
validate chem 10 calibration verification test set, model 110 MAINE STANDARDS CO. k023410 01/06/2003
electro-nerve stimulator tens model bmls02-2 BIOMEDICAL LIFE SYSTEMS k021270 02/06/2003
merit medical 1-ml syringe MERIT MEDICAL SYSTEMS, INC. k024052 02/21/2003

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