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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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arzzt 3.5 / 4.5 small & large fragments system TRUEMED GROUP, LLC k162507 08/03/2017
atr tecnika ADVANCED TECHNOLOGY RESEARCH (A.T.R.) S.R.P. k000547 05/03/2000
aurelia chlorinated powder free latex medical examination gloves with aloe vera and ginseng with protein labeling claim SUPERMAX GLOVE MANUFACTURING SDN BHD k013953 02/26/2002
autolens cleaning and disinfecting unit AUTOLENS INC. k021699 12/16/2002
automatic analyzer LACHAT CHEMICALS, INC. k771662 12/06/1977
avalon elite bi-caval dual lumen catheter, 13fr, 16fr, 19fr, 20fr, 23fr, 27fr, 31fr AVALON LABORATORIES, LLC k081820 10/06/2008
avs® al and align peek spacers, avs® pl and unilif peek spacers, avs® tl peek spacer, avs® navigator peek spacer, avs® aria peek spacer, acculif tl and pl cage, avs® anchor-l spacer, aero-al lumbar cage system STRYKER CORPORATION k143163 01/26/2015
axiom reg ANTHOGYR SAS k131066 02/21/2014
azur cx detachable 35 coils Micro Vention, Inc. k151358 09/25/2015
b-d heparinized longdwel i.v. catheter BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC k812137 11/06/1981

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