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
|
|
Correspondent Contact |
JEFFREY L AULL |
Regulation Number | 874.3495
|
Classification Product Code |
|
Subsequent Product Code |
|
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
|
|
|