COCHLEAR BAHA BP100

Hearing Aid, Bone Conduction

COCHLEAR BONE ANCHORED SYSTEMS AB

The following data is part of a premarket notification filed by Cochlear Bone Anchored Systems Ab with the FDA for Cochlear Baha Bp100.

Pre-market Notification Details

Device IDK090720
510k NumberK090720
Device Name:COCHLEAR BAHA BP100
ClassificationHearing Aid, Bone Conduction
Applicant COCHLEAR BONE ANCHORED SYSTEMS AB 13059 E. PEAKVIEW AVE. Centennial,  CO  80111
ContactSean Bundy
CorrespondentSean Bundy
COCHLEAR BONE ANCHORED SYSTEMS AB 13059 E. PEAKVIEW AVE. Centennial,  CO  80111
Product CodeLXB  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-03-18
Decision Date2009-06-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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09321502016681 K090720 000
09321502016698 K090720 000
09321502016704 K090720 000
09321502016711 K090720 000
09321502012812 K090720 000

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