Device Classification Name |
Dilator, Nasal
|
510(k) Number |
K942025 |
Device Name |
BURGET NASAL STENT |
Applicant |
BIVONA MEDICAL TECHNOLOGIES |
5700 WEST 23RD AVE. |
GARY,
IN
46406
|
|
Applicant Contact |
H. M KAUFMAN |
Correspondent |
BIVONA MEDICAL TECHNOLOGIES |
5700 WEST 23RD AVE. |
GARY,
IN
46406
|
|
Correspondent Contact |
H. M KAUFMAN |
Regulation Number | 874.3900
|
Classification Product Code |
|
Date Received | 04/26/1994 |
Decision Date | 10/27/1995 |
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
|
|
|