Device Classification Name |
Prosthesis, Nose, Internal
|
510(k) Number |
K903328 |
Device Name |
CUI PREMAXILLARY IMPLANT |
Applicant |
CUI CORP. |
P.O. BOX 40288 |
SANTA BARBARA,
CA
93140
|
|
Applicant Contact |
MORRIS SHERWOOD |
Correspondent |
CUI CORP. |
P.O. BOX 40288 |
SANTA BARBARA,
CA
93140
|
|
Correspondent Contact |
MORRIS SHERWOOD |
Regulation Number | 878.3680
|
Classification Product Code |
|
Date Received | 07/25/1990 |
Decision Date | 09/10/1990 |
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
|