| Device Classification Name |
Button, Nasal Septal
|
| 510(k) Number |
K850492 |
| Device Name |
NASAL SEPTAL BUTTON |
| Applicant |
| Santa Barbara Medco, Inc. |
| P.O. Box 6843 |
|
Santa Barbara,
CA
93111
|
|
| Applicant Contact |
DAVID G ESSLINGER |
| Correspondent |
| Santa Barbara Medco, Inc. |
| P.O. Box 6843 |
|
Santa Barbara,
CA
93111
|
|
| Correspondent Contact |
DAVID G ESSLINGER |
| Classification Product Code |
|
| Date Received | 02/08/1985 |
| Decision Date | 03/07/1985 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Ear Nose & Throat
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|