Device Classification Name |
Prosthesis, Facial, Mandibular Implant
|
510(k) Number |
K901923 |
Device Name |
INVOTEC POLY-MESH MANDIBULAR TRAY |
Applicant |
INVOTEC INTERNATIONAL, INC. |
11330-1ST. JOHN'S INDUSTRIAL |
PARKWAY |
JACKSONVILLE,
FL
32216
|
|
Applicant Contact |
JEFFREY L AULL |
Correspondent |
INVOTEC INTERNATIONAL, INC. |
11330-1ST. JOHN'S INDUSTRIAL |
PARKWAY |
JACKSONVILLE,
FL
32216
|
|
Correspondent Contact |
JEFFREY L AULL |
Regulation Number | 874.3695
|
Classification Product Code |
|
Date Received | 04/30/1990 |
Decision Date | 10/31/1990 |
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
|
|
|