Device Classification Name |
Device, Fixation, Tracheal Tube
|
510(k) Number |
K924551 |
Device Name |
ENDO TRACHEA TUBE FIXATION |
Applicant |
M. IMONTI AND ASSOCIATES INC., |
25707 COMPASS WAY |
SAN JUAN CAPISTRANO,
CA
92675
|
|
Applicant Contact |
MAURICE IMONTI |
Correspondent |
M. IMONTI AND ASSOCIATES INC., |
25707 COMPASS WAY |
SAN JUAN CAPISTRANO,
CA
92675
|
|
Correspondent Contact |
MAURICE IMONTI |
Regulation Number | 868.5770
|
Classification Product Code |
|
Date Received | 09/09/1992 |
Decision Date | 12/08/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|