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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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lifescreen apnea DEL MAR REYNOLDS MEDICAL, INC. k042745 01/19/2005
charlotte high-demand compression screw WRIGHT MEDICAL TECHNOLOGY, INC. k043281 01/19/2005
r2-mri analysis system INNER VISION BIOMETRICS PTY LTD k043271 01/21/2005
intuitive surgical monopolar curved scissors, model 400179; tip cover accessory, model 400180 INTUITIVE SURGICAL, INC. k050005 01/25/2005
theraload custom loaded needles, models 200 and 125.s06 THERAGENICS CORP. k043596 01/26/2005
fusion fast GC AMERICA, INC. k043471 01/27/2005
neuromonics tinnitus treatment NEUROMONICS PTY LTD k043274 01/28/2005
mindstate functional data acquisition device, version 1.0 NEUROGNOSTICS, INC. k043290 01/28/2005
radin, model v 3.0 SOHARD AG k043483 01/28/2005
evis exera colonovideoscope model xcf-q160w1l/1 AIZU OLYMPUS CO., LTD. k043487 01/28/2005

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