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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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nexflex total hip system ALPHATEC/NEXMED k042252 12/06/2004
sleepsense sleep sensors S.L.P. LTD. k042253 10/06/2004
pmp4 selfcheck ecg CARD GUARD SCIENTIFIC SURVIVAL, LTD. k042254 01/13/2005
ir heat lamp systems: icl 15 hfpl system, icl 60 plus hfpl system (models 40, 100 and 250), icl 100 activo scanner syste USA LASER BIOTECH INC. k042256 11/17/2004
discovery st pet/ct imaging system with an alternate detector option GENERAL ELECTRIC CO. k042257 09/08/2004
bp-spect v1.o SYNTERMED, INC. k042258 10/04/2004
phot-x ii, model 303 TAKARA BELMONT USA, INC. k042260 09/07/2004
macropore puricel lipoplasty system MACROPORE BIOSURGERY, INC. k042261 09/20/2004
integra oxygen concentrator, model 6323a-om-10 SEQUAL TECHNOLOGIES, INC. k042262 09/10/2004
guidewires ROCKET MEDICAL PLC k042264 11/24/2004

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