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U.S. Department of Health and Human Services

510(K) Premarket Notification

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Device Name
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Applicant
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510(K)
Number
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Decision
Date
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prospore2 self-contained biological indicator RAVEN BIOLOGICAL LABORATORIES, INC. k994381 03/30/2001
rx daytona plus chemistry analyzer; rx daytona plus aspartate aminotransferase (ast) reagent RANDOX LABORATORIES, LTD. k131554 01/09/2014
radius 018 cougar wire RADIUS MEDICAL TECHNOLOGIES, INC. k032129 07/17/2003
abl90 flex RADIOMETER MEDICAL APS k123748 05/07/2013
quill synthetic absorbable barbed suture QUILL MEDICAL, INC. k042075 10/26/2004
quest mps perfusion assisted direct coronary artery bypass (padcab) QUEST MEDICAL, INC. k994274 05/31/2000
fastpack psa immunoassay, fastpack system QUALISYS DIAGNOSTICS, INC. k994419 06/28/2000
powder free latex examination patient gloves PURNABINA SDN BHD k994420 09/18/2000
pure water-cds (central dialysis solution) PURE WATER SOLUTIONS, INC. k994279 12/22/2000
glovetex, latex examination gloves, powdered non-sterile.(protein content labeling) PT. WRP BUANA MULTICORPORA k994426 05/23/2000

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