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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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stat-site mhgb meter, stat-site mhgb meter card holder, stat-site mhgb test cards, stat-site mhgb code way, models 90090 GDS TECHNOLOGY k020138 02/11/2002
modification to ebi xfix vision fixation system EBI, L.P. k020141 02/05/2002
phoenix eletrolyte calibration set for the roche cobas ise module PHOENIX DIAGNOSTICS, INC. k020129 02/01/2002
voxar's calcium scoring product VOXAR LIMITED k020140 01/28/2002
modification to the maestro system BIOHORIZONS IMPLANT SYSTEMS, INC. k020133 01/25/2002
prolite pulsed light system for the removal of unwanted hair MEDICAL BIO CARE SWEDEN AB k013366 01/08/2002
modification to leksell surgiplan with atlaspace ELEKTA INSTRUMENT AB k013861 12/06/2001
model mes-9000/emg system MYOTRONICS-NOROMED, INC. k013399 11/13/2001
lifejet video link FERRANIA S.P.A. k013395 10/30/2001
sodem high speed system (electric) (general orthopedics & plastic surgery) SODEM SYSTEMS k012453 10/22/2001

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