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U.S. Department of Health and Human Services

510(K) Premarket Notification

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510(K)
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Decision
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st aia-pack intact pth assay Tosoh BioScience, Inc. k063605 06/21/2007
aquilion one vision, v7.0 TOSHIBA MEDICAL SYSTEMS CORPORATION k142465 03/10/2015
tornier aequalis adjustable reverse shoulder system TORNIER, INC. k141029 06/18/2014
harmony Topcon Medical Systems, Inc. k182376 09/28/2018
imagenet 6 ophthalmic data system Topcon Corporation k171370 11/01/2017
endoskeleton® tas interbody fusion device, endoskeleton® tas hyperlordotic interbody fusion device and endoskeleton® tcs interbody fusion device Titan Spine, LLC k173535 02/13/2018
customized sound therapy (cst) TINNITUS OTOSOUND PRODUCTS, LLC k070599 07/13/2007
if series true sine interferential stimulator/model: wl-2206, well if, life if and the customer private brand THERATECH, INC. k024100 02/25/2003
if true sine interferential stimulator, model wl-2206a THERATECH, INC. k050847 06/17/2005
manta ray anterior cervical plate system THEKEN SPINE LLC k080690 04/25/2008

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