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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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triton/tru-trac/tx traction devices CHATTANOOGA GROUP k051938 09/21/2005
tripter-x1 compact duet sp (separated pulse) DIREX SYSTEMS CORP. k050091 03/16/2005
triple-fix spinal fixation system ADVANCED SPINE TECHNOLOGY, INC. k992147 02/28/2000
trip tonometry catheter, 8f DATEX-OHMEDA, INC. k992181 08/24/1999
trimed osteotomy plate TRIMED, INC. k043263 01/14/2005
travel ease electric scooter, model pioneer 3 MERITS HEALTH PRODUCTS., INC. k011751 08/06/2001
trauson bone screw, models ha 3.5 and 4.5 TRAUSON (JIANGSU) MEDICAL INSTRUMENT CO., LTD. k073159 07/23/2008
transvaginal ultrasound probe holder device RON-TECH MEDICAL LTD. k992071 08/27/1999
thrombigel thrombin/gelatin foam hemostat VASCULAR SOLUTIONS, INC. k063860 02/13/2007
third eye retroscope auxiliary endoscopy system AVANTIS MEDICAL SYSTEMS, INC. k070330 04/24/2007

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