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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 10 Results
ProductCode: LXB Applicant: COCHLEAR AMERICAS Decision Date To: 09/27/2020
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510(K)
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cochlear baha soundarc Cochlear Americas K171088 06/07/2017
baha 5 power sound processor Cochlear Americas K161123 05/20/2016
baha 5 super power sound processor COCHLEAR AMERICAS K153245 03/02/2016
cordelle ii sound processor COCHLEAR AMERICAS K150751 07/22/2015
baha 5 sound processor COCHLEAR AMERICAS K142907 03/25/2015
cochlear baha implant system, cochlear baha attract COCHLEAR AMERICAS K131240 11/07/2013
cochlear baha 4 sound processor COCHLEAR AMERICAS K132278 09/26/2013
baha 3 power sound processor COCHLEAR AMERICAS K110996 05/10/2011
bia300 series implant and abutment, bi300 implant, ba300 abutment COCHLEAR AMERICAS K100360 07/13/2010
baha intenso COCHLEAR AMERICAS K081606 08/28/2008
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