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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
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sheathes ultrasond gel SHEATHING TECHNOLOGIES, INC. k112827 06/22/2012
shaker digital thermometer MEASURE TECHNOLOGY CO. LTD. k112703 10/04/2011
sentinel plasmaproteins cal 3x SENTINEL CH. SpA k081533 06/25/2008
sensititre 18-24 hours susceptibility plates (gatifloxacin) TREK DIAGNOSTIC SYSTEMS, INC. k001035 05/23/2000
sensaid, models# rc-nva30-10; rc-cs140-10; rc-bc150-3 SENSIDYNE, INC. k021246 05/13/2002
seal-away cs introducer kit, models 407514, 407515 ST. JUDE MEDICAL k013029 10/09/2001
scanwave pen (with light gray cord), scanwave pen (with medium gray cord), scanwave pen (with dark gray cord), scanwave SATELEC-ACTEON GROUP k131906 04/11/2014
saview-aqua 58 uv (etafilcon a) visibility tinted soft (hydrophilic) contact lens, saview-aqua 58 uv toric (etafilcon a) ST. SHINE OPTICAL CO., LTD. k132146 08/30/2013
sauflon multipurpose solution - no rub SAUFLON PHARMACEUTICALS, LTD. k030278 07/30/2003
sarns high flow aortic arch cannula TERUMO CARDIOVASCULAR SYSTEMS CORP. k133151 02/03/2014

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