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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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hero 1, model ly-esb220 COMFORT ORTHOPEDIC CO. LTD. k031621 01/22/2004
histofreezer wart removal system or other proprietary name ORASURE TECHNOLOGIES, INC. k023487 03/20/2003
hologic visceral fat software HOLOGIC, INC. k113356 03/06/2012
humelock ii cementless shoulder system FX SOLUTIONS k130759 11/09/2013
hygia health services reprocessed nellcot d-25 oxisensor ii HYGIA HEALTH SERVICES, INC. k012715 08/01/2003
ic-1545-dl multi flo dvt combo intermittent pneumatic compression device BIO COMPRESSION SYSTEMS, INC. k131306 07/22/2013
ideal: system with integrated venous air removal, centrifugal blood pump, pump bracket, adult membrane oxygenator DIDECO S.P.A. k030154 03/31/2003
ids-isys 25-hydroxy vitamin ds, and ids-isys 25 hydroxy vitamin ds control set IMMUNODIAGNOSTIC SYSTEMS LTD. k140554 12/19/2014
ifis-sa integrated fuctional imaging system MRI DEVICES CORP. k003899 03/15/2001
ifuse implant system SI-BONE, INC. k122074 10/12/2012

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