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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
Date
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sofia(r) hcg fia QUIDEL CORP. k131166 08/02/2013
heart sync HEART SYNC INC. k131550 12/06/2013
glide device HOME SKINOVATIONS LTD. k131870 08/14/2013
mr810respiratory humidifier, 900mr810 adult single limb circuit, 900mr810e adult dual limb circuit FISHER & PAYKEL HEALTHCARE, LTD. k131957 12/04/2013
removable patient leads ecg cable BOSTON SCIENTIFIC k132253 12/16/2013
coated vicryl plus antimicrobial (polyglactin 910) synthetic absorbable suture ETHICON, INC. k132580 02/28/2014
elecsys calcitonin; immunoassay, calset, calcheck 5; elecsys precicontrol varia 3 Roche Diagnostics k132828 12/04/2013
speed 808 diode laser system BEIJING TOPLASER TECHNOLOGY CO., LTD. k132989 01/23/2014
eclipse treatment planning system VARIAN MEDICAL SYSTEMS, INC. k133247 02/07/2014
hepatic vcar GE MEDICAL SYSTEMS SCS k133649 04/22/2014

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