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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
Date
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base metal alloy DENTSPLY INTL. k811258 07/23/1981
baumer locking nail BAUMER S.A. k011504 08/14/2001
bausch + lomb (kalifilcon a) soft contact lens, bausch + lomb (kalifilcon a) soft contact lens for astigmatism Bausch + Lomb, Incorporated k200528 06/02/2020
bci ww1021 pc application SMITHS MEDICAL PM, INC. k090205 04/28/2009
bd max vaginal panel, bd max instrument GENEOHM SCIENCES CANADA , INC (BD DIAGNOSTICS) den160001 10/28/2016
bd single lumen needle, syringe and blood collection set BD k021475 07/19/2002
beam modulator, model 4513 332 8000 ELEKTA LTD. k042794 01/31/2005
behind-the-ear hearing aid #8003 DANAVOX, INC. k823531 12/15/1982
benchmark intracranial access system PENUMBRA, INC. k142321 01/26/2015
biosci™ inactivated transport medium, biosci™ itm Shenzhen Dakewe Bio-engineering Co., Ltd. k220059 01/19/2023

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