| Device Classification Name |
splint, intranasal septal
|
|---|
| 510(k) Number |
K935053 |
|---|
| Device Name |
BIVONA NASAL TURBINATE STENT |
|---|
| Applicant |
| BIVONA MEDICAL TECHNOLOGIES |
| 5700 WEST 23RD AVE. |
|
GARY,
IN
46406
|
|
| Applicant Contact |
HARRY M KAUFMAN |
| Correspondent |
| BIVONA MEDICAL TECHNOLOGIES |
| 5700 WEST 23RD AVE. |
|
GARY,
IN
46406
|
|
| Correspondent Contact |
HARRY M KAUFMAN |
| Regulation Number | 874.4780
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 10/21/1993 |
|---|
| Decision Date | 07/01/1994 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Ear Nose & Throat
|
|---|
| 510k Review Panel |
Ear Nose & Throat
|
|---|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|