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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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ensite verismo software ST. JUDE MEDICAL k051840 08/15/2005
cps aim inner catheter, models 410140, 410141, 410142, 410144, 410145, 410146, 410147, 410148 ST. JUDE MEDICAL k053217 03/08/2006
simplechoice 3.0 ml reservoir pro reference number rp-30 SPECTRX, INC. k051045 08/02/2005
spectra hair removal laser SPECTRAGENICS, INC. k052848 12/27/2005
ambit push & play ambulatory infusion pump SORENSON MEDICAL, INC. k052221 12/08/2005
polaris pressure adjustable valve system, models spv-140, spv-300, spv-400 SOPHYSA SA k042481 12/14/2004
ssi-600/ssi-800 diagnostic ultrasound imaging system SONOSCAPE COMPANY LIMITED k041455 06/10/2004
sonoscape ssi-1000/ssi-5000 ultrasound transducers SONOSCAPE COMPANY LIMITED k052042 08/09/2005
the 4cis spinal system and 4cis low back system SOLCO BIOMEDICAL CO., LTD. k043578 03/07/2005
aquinox SMITHS MEDICAL ASD, INC. k050314 02/18/2005

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