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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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modification to: reaads anti-phosphatidylserine igg/igm semi-quantitative test kit CORGENIX, INC. k012567 08/23/2001
trocar sleeve and accessories, models 1287-xx-xx PAJUNK GMBH k012771 11/14/2001
smartflow FLORENCE MEDICAL LTD. k012947 10/02/2001
mt alert infusion monitor SIERRA BIOSEARCH INC k013121 10/15/2001
monarch spinal systems DEPUY ACROMED k013294 10/09/2001
isobar spinal system SCIEN'TX USA INC. k013444 11/16/2001
babies best water teether / gum soother, various BABIES BEST, INC. k013587 05/14/2002
rose k post graft lens ROSE K INTERNATIONAL LTD. k013646 05/30/2002
global healthcare vaginal speculum DYNASCEND CONSULTING INT'L LLC. k013835 01/17/2002
hemochron jr. citrate aptt cuvette ITC, INC. k014008 01/24/2002

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