Device Classification Name |
prosthesis, nose, internal
|
510(k) Number |
K962824 |
Device Name |
IMPLANTECH JEJ PERI-PYRIFORM IMPLANT |
Applicant |
IMPLANTECH ASSOCIATES, INC. |
1730 PENNSYLVANIA AVENUE, NW |
WASHINGTON,
DC
20006
|
|
Applicant Contact |
EDWARD M BASILE |
Correspondent |
IMPLANTECH ASSOCIATES, INC. |
1730 PENNSYLVANIA AVENUE, NW |
WASHINGTON,
DC
20006
|
|
Correspondent Contact |
EDWARD M BASILE |
Regulation Number | 878.3680
|
Classification Product Code |
|
Date Received | 07/19/1996 |
Decision Date | 10/03/1996 |
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
|
|
|