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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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modification to the watchchild obstetrical patient data management system HILL-ROM MANUFACTURING, INC. k014094 01/11/2002
easylistener 2 fm, radium fm and vocalight infrared sound field systems PHONIC EAR, INC. k043090 12/23/2004
neuromonics tinnitus treatment NEUROMONICS PTY LTD k043274 01/28/2005
powderfree polychloroprene sterilized surgical gloves with aloe vera and vitamin e PT. MEDISAFE TECHNOLOGIES k042567 01/13/2005
ultradent carbon mask - upi #342 MEDSPRING GROUP, INCORPORATED k041047 12/01/2004
modification to coulter lh 500 hematology analyzer BECKMAN COULTER, INC. k042724 10/29/2004
panbus digital eeg & sleep acquisition devices LAMONT MEDICAL INC k042364 09/30/2004
binaxnow influenza a & b test BINAX, INC. k041049 08/10/2004
avita piccolo/exato infared ear thermometer (ts2 & ts4 series) AVITA CORPORATION k010462 04/11/2001
lineage ha acetabular shells WRIGHT MEDICAL TECHNOLOGY, INC. k043099 09/29/2005

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