Device Classification Name |
balloon, epistaxis
|
510(k) Number |
K900583 |
Device Name |
MODIFIED BIVONA EPISTAXIS CATHETER |
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 | 874.4100
|
Classification Product Code |
|
Date Received | 02/07/1990 |
Decision Date | 08/09/1990 |
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
|
|
|