TITANIUM MIDDLE EAR PROSTHESES


codes

Device Classification Name

prosthesis, partial ossicular replacement

510(k) Number K002897
Device Name TITANIUM MIDDLE EAR PROSTHESES
Original Applicant
XOMED, INC.
6743 southpoint dr. north
jacksonville, 
FL 
32216 -0980

Original Contact david timlin
Regulation Number 874.3450
Classification Product Code
ETB  
Subsequent Product Code
ETA  
Date Received 09/18/2000
Decision Date 10/11/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ear Nose & Throat

510k Review Panel

Ear Nose & Throat

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls
Category: Uncategorized