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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)
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Decision
Date
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factor v leiden kit ROCHE DIAGNOSTICS CORP. den030005 12/17/2003
assuretech panel dip test, assuretech quick cup test ASSURE TECH (HANGZHOU) CO., LTD. k170049 05/02/2017
contact lens case (multiple brand name) DANYANG CHANXIN GLASSES CASES FACTORY k160005 06/07/2016
advocate insulin pen needles Diabetic Supply of Suncoast, Inc. k160199 10/19/2016
adtec AESCULAP, INC. k160393 05/26/2016
universal cylinder applicator family, universal segmented cylinder applicator set, universal stump applicator set, universal cervix probe set, odd lengths, universal cervix probe set, even lengths Varian Medical Systems, Inc k160516 08/10/2016
cure™ anterior cervical plate (acp) system MEDITECH SPINE, LLC k160604 07/01/2016
4.0 and 6.5 cancellous bone screw and washer SMV SCIENTIFIC k160946 12/05/2016
latex powder free polymer coated examination glove with protein labeling claim of 50 microgram or less per gram of glove HARTALEGA SDN. BHD. k161006 08/04/2016
multipulse hoplus ASCLEPION LASER TECHNOLOGIES GMBH k161257 03/31/2017

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