| Device Classification Name |
Laryngoscope, Rigid
|
| 510(k) Number |
K882659 |
| Device Name |
AUGUSTINE INTUBATION GUIDE(TM) |
| Applicant |
| Augustine Medical, Inc. |
| 1601 Stonecrest Court |
|
Blue Springs,
MO
64015
|
|
| Applicant Contact |
D AUGUSTINE |
| Correspondent |
| Augustine Medical, Inc. |
| 1601 Stonecrest Court |
|
Blue Springs,
MO
64015
|
|
| Correspondent Contact |
D AUGUSTINE |
| Regulation Number | 868.5540 |
| Classification Product Code |
|
| Date Received | 06/28/1988 |
| Decision Date | 07/21/1988 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Anesthesiology
|
| 510k Review Panel |
Anesthesiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|