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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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rapidia 3D MED CO., LTD. k012290 09/28/2001
cannabinoids ABBOTT LABORATORIES k013247 03/13/2002
medisense precision pcx point of care management system for blood glucose testing ABBOTT LABORATORIES k022941 10/28/2002
acist 4 french angiographic catheter ACIST MEDICAL SYSTEMS, INC. k012983 03/13/2002
dual lumen catheter ACMI CORPORATION k043581 03/03/2005
acumen sheath, model ttw7807 ACUMEN MEDICAL, INC. k042376 10/26/2004
coronary sinus visualization system, model csvs5508 ACUMEN MEDICAL, INC. k042381 12/28/2004
modified acumen sheath, model ttwo767 ACUMEN MEDICAL, INC. k050015 02/03/2005
huanqiu and super (two brands) sterile acupuncture needle for single use ACUSUPPLY, INC. k011242 09/11/2001
ensphere tempo jetstream workspace cardiology module ADAC LABORATORIES k040142 02/06/2004

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