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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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zynergy z5000 electrophysiology catheter with z9000 accessory cable ZYNERGY CARDIO VASULAR (ZCV), INC. k011847 07/13/2001
zybit ZYMED MEDICAL INSTRUMENTATION k002004 09/21/2000
zoll pad ZOLL MEDICAL CORP. k011388 03/25/2002
zoll m series ibp operation; zoll m series temperature option ZOLL MEDICAL CORP. k011865 07/31/2001
zeus microwrist robotic surgical system COMPUTER MOTION, INC. k013551 03/28/2002
xtrac excimer laser system, model al7000 PHOTO MEDEX, INC. k020847 05/16/2002
xtrac excimer laser system, model al 7000 PHOTO MEDEX, INC. k011382 08/02/2001
xterra gt power wheelchair INVACARE CORP. k012909 10/24/2001
xtd thrombectomy catheter, xx cm, model# ct000500x; xtd control console, model # ct0006001; xtd collection bottle, model XTRAK MEDICAL INC. k013473 03/06/2002
xenf-dp rhino-laryngofiberscope, its accessories and ancillary equipment THE OLYMPUS OPTICAL CO. k011869 07/25/2001

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