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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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salto xt, salto talaris Tornier SAS k153452 08/11/2016
a1 glove powder free latex patient examination gloves with protein content labeling claim (contains 50 micrograms per dm2 of glove or less of water extractable protein) A1 GLOVE SDN BHD k153744 08/04/2016
aesculap histoacryl, histoacryl blue and histoacryl flexible topical skin, adhesive with applicator tip AESCULAP, INC. k140343 05/13/2014
zquiet-sa SLEEPING WELL, LLC k140777 07/25/2014
artimes balloon dilatation catheter BROSMED MEDICAL k141025 09/12/2014
a&d medical ua-651 digital blood pressure monitor A & D CO., LTD. k141160 10/07/2014
neonatal venous hardshell cardiotomy reservior, pediatric venous hardshell cardiotomy reservior, neonatal venous hardhsh MAQUET CARDIOPULMONARY AG k141432 07/07/2014
silverlon island wound dressing ARGENTUM MEDICAL k141573 08/28/2014
bulk fill flowable composite NOVOCOL, INC. k141994 11/14/2014
rapidfret oral fluid assay for cocaine, rapidfret oral fluid cocaine calibrator set, rapidfret oral fluid cocaine control set BIOPHOR DIAGNOSTICS, INC. k142129 07/24/2015

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