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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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combison 301 pw ultrasound system and transducers MEDISON CO., LTD. k002491 08/25/2000
simplicity soft infusion set STERLING MEDIVATIONS, INC. k002492 10/24/2000
dideco micro 40 ph.i.s.i.o (phosphorylcholine insert surface in oxgenation) newborn/infant arterial filter COBE CARDIOVASCULAR, INC. k002493 11/30/2000
model 4815 adapter PACE MEDICAL k002496 10/10/2000
model 4810 analyzer output adapter PACE MEDICAL k002497 10/10/2000
brentwood iqmark digital spirometer (includes disposable pneumotach mouthpieces and 3-liter calibration syringe BRENTWOOD MEDICAL TECHNOLOGY CORP. k002499 11/08/2000
x-posure system version 2 rad PRONOSCO A/S k002500 10/23/2000
ceram-prime S & C POLYMER GMBH k002502 11/08/2000
careside cholinesterase CARESIDE, INC. k002792 11/08/2000
ketac cem u ESPE DENTAL AG k002793 09/26/2000

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