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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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concert radiopaque bone cement IMMEDICA, INC. k013755 02/08/2002
synthes metallic spiked washers SYNTHES (USA) k013806 02/08/2002
testosterone by enzymeimmunoassay (eia) DIAGNOSTICS BIOCHEM CANADA, INC. k014120 02/08/2002
pgd-pre-implantation genetic diagnostic pipettes (biopsy pipettes) COOK UROLOGICAL, INC. k014160 02/08/2002
gelzone IMPLANTECH ASSOCIATES, INC. k013732 02/07/2002
d.sign 59 IVOCLAR VIVADENT, INC. k013809 02/07/2002
extoral/tescera glazing resin, model t-1804 AFP IMAGING CORP. k014144 02/07/2002
brentwood real time st and arrhythmia analysis software library BRENTWOOD MEDICAL TECHNOLOGY CORP. k013717 02/06/2002
modification to: eub-6500 diagnostic ultrasound scanner HITACHI MEDICAL CORP. k013723 02/06/2002
ariel radio frequency (rf) electrosurgical control module and accessories NOVASYS MEDICAL, INC. k013730 02/06/2002

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