Device Classification Name |
prosthesis, nose, internal
|
510(k) Number |
K921580 |
Device Name |
BRINK PRE-MAXILLARY IMPLANT |
Applicant |
IMPLANTECH ASSOCIATES, INC. |
1730 PENNSYLVANIA AVENUE, NW |
WASHINGTON,
DC
20006
|
|
Applicant Contact |
JOAN E HANKIN |
Correspondent |
IMPLANTECH ASSOCIATES, INC. |
1730 PENNSYLVANIA AVENUE, NW |
WASHINGTON,
DC
20006
|
|
Correspondent Contact |
JOAN E HANKIN |
Regulation Number | 878.3680
|
Classification Product Code |
|
Date Received | 04/02/1992 |
Decision Date | 05/06/1992 |
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
|
|
|