Device Classification Name |
tube, tracheal (w/wo connector)
|
510(k) Number |
K862238 |
Device Name |
BIVONA FOME-CUF LASER ENDOTRACHEAL TUBE |
Applicant |
BIVONA MEDICAL TECHNOLOGIES |
5700 WEST 23RD AVE. |
GARY,
IN
46406
|
|
Applicant Contact |
SHAPIRO, M.D. |
Correspondent |
BIVONA MEDICAL TECHNOLOGIES |
5700 WEST 23RD AVE. |
GARY,
IN
46406
|
|
Correspondent Contact |
SHAPIRO, M.D. |
Regulation Number | 868.5730
|
Classification Product Code |
|
Date Received | 06/12/1986 |
Decision Date | 10/15/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|