BA400 14mm Abutment

Hearing Aid, Bone Conduction, Implanted

COCHLEAR AMERICAS

The following data is part of a premarket notification filed by Cochlear Americas with the FDA for Ba400 14mm Abutment.

Pre-market Notification Details

Device IDK150555
510k NumberK150555
Device Name:BA400 14mm Abutment
ClassificationHearing Aid, Bone Conduction, Implanted
Applicant COCHLEAR AMERICAS 13059 E PEAKVIEW AVE Centennial,  CO  80111
ContactTristan Manus
CorrespondentTristan Manus
COCHLEAR AMERICAS 13059 E PEAKVIEW AVE Centennial,  CO  80111
Product CodeMAH  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-03-04
Decision Date2015-07-15

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
09321502028202 K150555 000
09321502033886 K150555 000
09321502033459 K150555 000
09321502033442 K150555 000

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