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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
Date
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alden hp (hioxifilcon b) sphere & toric soft contact lenses ALDEN OPTICAL LABS., INC. k042242 09/15/2004
microalbumin multi-calibrator set DIAGNOSTIC CHEMICALS LTD. k042243 10/04/2004
bone-lok mvp cortical-cancellous compression device TRIAGE MEDICAL, INC. k042244 09/16/2004
vapotherm model#2000i, 200h VAPOTHERM, INC. k042245 08/30/2004
multi-drip infusion catheter ADVANCED INFUSION, INC. k042246 08/31/2004
synthetic (blue) vinyl patient examination gloves - powder free SHIJIAZHUANG HONGXIANG PLASTICS PRODUCTS CO., LTD k042247 09/02/2004
kronus, inc.'s acetylcholine receptor antibody (achrab) assay kit KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. k042248 12/17/2004
cls spotorno stem ZIMMER AUSTIN, INC. k042249 09/15/2004
sensatouch ALUNA MANAGEMENT CO., LTD. k042250 11/12/2004
bayer advia 2120 hematology analyzer with autoslide system BAYER HEALTHCARE, LLC k042251 09/17/2004

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