Device Classification Name |
prosthesis, chin, internal
|
510(k) Number |
K911514 |
Device Name |
ARTICULATED CHIN IMPLANT |
Applicant |
IMPLANTECH ASSOCIATES, INC. |
1730 PENNSYLVANIA AVENUE, NW |
WASHINGTON,
DC
20006
|
|
Applicant Contact |
DVORAH A RICHMAN |
Correspondent |
IMPLANTECH ASSOCIATES, INC. |
1730 PENNSYLVANIA AVENUE, NW |
WASHINGTON,
DC
20006
|
|
Correspondent Contact |
DVORAH A RICHMAN |
Regulation Number | 878.3550
|
Classification Product Code |
|
Date Received | 04/04/1991 |
Decision Date | 07/01/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|