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U.S. Department of Health and Human Services

510(K) Premarket Notification
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510(K)
Number
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Decision
Date
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am-bio extended range series dialyzer, models wet and dry ASAHI MEDICAL CO., LTD k013418 07/09/2002
easi 12 lead algorithm PHILIPS MEDICAL SYSTEMS k020456 07/09/2002
rusch floneil; flocath introgel RUSCH INTL. k020714 07/01/2002
uhi-3 high flow insufflation unit OLYMPUS OPTICAL CO., LTD. k014166 06/25/2002
laminaria 2mm/3mm/4mm/5mm/6mm/7mm/8mm/9mm QUALITY MEDICAL SOLUSIONS LLC k021012 06/25/2002
castle peracetic acid biological indicator kit GETINGE/CASTLE, INC. k020205 06/24/2002
absorbent antimicrobial wound dressing CONVATEC, A DIVISION OF E.R. SQUIBB & SONS k013814 06/21/2002
afb (absorbable foam buttress) J&J CORPORATE BIOMATERIALS CENTER k014183 06/12/2002
system 100; s-100 ultrafiltration console; bdt 500 ultrafiltration set CHF SOLUTIONS, INC. k013733 06/03/2002
enteryx injector ENTERIC MEDICAL TECHNOLOGIES k013712 05/31/2002

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