TITANIUM MIDDLE EAR PROSTHESES

Prosthesis, Partial Ossicular Replacement

XOMED, INC.

The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Titanium Middle Ear Prostheses.

Pre-market Notification Details

Device IDK002897
510k NumberK002897
Device Name:TITANIUM MIDDLE EAR PROSTHESES
ClassificationProsthesis, Partial Ossicular Replacement
Applicant XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville,  FL  32216 -0980
ContactDavid Timlin
CorrespondentDavid Timlin
XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville,  FL  32216 -0980
Product CodeETB  
CFR Regulation Number874.3450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-09-18
Decision Date2000-10-11

NIH GUDID Devices

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