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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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510(K)
Number
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Decision
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tray adapters, multiple ARPLAY MEDICAL S.A. k010174 04/18/2001
transamerica digital ems TRANSAMERICA MEDICAL SYSTEMS k010665 04/27/2001
total cure BISCO, INC. k010196 04/05/2001
tornier total elbow prosthesis TORNIER k000003 10/02/2000
thrombelastograph coagulation analyzer teg-5000 series HAEMOSCOPE CORP. k002177 09/14/2000
thermofx mesh BIONX IMPLANTS, LTD. k003757 02/07/2001
thermo tek ir forehead thermometer, model 718f S.A.A.T., LTD. k002712 02/08/2001
the o'neil sterile field urinary catheter kit with prep pads GO MEDICAL INDUSTRIES PTY. LTD. k011055 06/06/2001
the lifecore stage-1 single stage rbm dental implant system LIFECORE BIOMEDICAL, INC. k003226 01/12/2001
tetrad tc-c3-acp TETRAD CORP. k002193 05/04/2001

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