TITANIUM OSSICULAR REPLACMENT SYSTEM


Device Classification Name

replacement, ossicular prosthesis, total

510(k) Number K030492
Device Name TITANIUM OSSICULAR REPLACMENT SYSTEM
Applicant
INVOTEC INTERNATIONAL, INC.
6833 phillips industrial blvd.
jacksonville, 
FL 
32256 -3029

Applicant Contact jeffrey l aull
Correspondent
INVOTEC INTERNATIONAL, INC.
6833 phillips industrial blvd.
jacksonville, 
FL 
32256 -3029

Correspodent Contact jeffrey l aull
Regulation Number 874.3495
Classification Product Code
ETA  
Subsequent Product Code
ETB  
Date Received 02/19/2003
Decision Date 03/03/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ear Nose & Throat

510k Review Panel

Ear Nose & Throat

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No