MODIFIED IMPLANT FOR XOMED AUDIANT BONE CONDUCTOR

Hearing Aid, Bone Conduction

XOMED, INC.

The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Modified Implant For Xomed Audiant Bone Conductor.

Pre-market Notification Details

Device IDK884056
510k NumberK884056
Device Name:MODIFIED IMPLANT FOR XOMED AUDIANT BONE CONDUCTOR
ClassificationHearing Aid, Bone Conduction
Applicant XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville,  FL  32216 -0980
ContactR Bruce
CorrespondentR Bruce
XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville,  FL  32216 -0980
Product CodeLXB  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-09-26
Decision Date1988-11-30

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