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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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modification to carto ep navigation system BIOSENSE WEBSTER, INC. k000190 05/05/2000
modification to acryderm silver antimicrobial wound dressing, models 1041, 1042, 1043, 1044, 1045 ACRYMED, INC. k002599 09/21/2000
modification of fixion intramedullary nailing system (fixion im nail) DISCO-O-TECH MEDICAL TECHNOLOGIES, LTD. k003215 12/27/2000
model hybrid 3200 monoplace, hyperbaric therapy systems HYPERTEC, INC. k002795 12/06/2000
model 5000 multiplace hyperbaric therapy HYPERTEC, INC. k002794 12/06/2000
model 473si-64e quadrature lower extremity coil IGC-MEDICAL ADVANCES, INC. k001312 06/20/2000
model 4300 psarray eeg electrode set PHYSIOMETRIX, INC. k001055 05/11/2000
model 4000 eeg monitor with psi (psa4000) PHYSIOMETRIX, INC. k001069 06/30/2000
model 120, oxysoft, infrared data converter, model 120 PALCO LABS, INC. k002787 11/29/2000
minimed paradigm insulin pump, model 511 MINIMED, INC. k001829 08/18/2000

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