| Device Classification Name |
Laryngoscope, Rigid
|
| 510(k) Number |
K851705 |
| Device Name |
LARYNGOSCOPE |
| Applicant |
| Armstrong Ind., Inc. |
| 3660 Commercial Ave. |
| P.O. Box 7 |
|
Northbrook,
IL
60062
|
|
| Applicant Contact |
KAREN BOWERS |
| Correspondent |
| Armstrong Ind., Inc. |
| 3660 Commercial Ave. |
| P.O. Box 7 |
|
Northbrook,
IL
60062
|
|
| Correspondent Contact |
KAREN BOWERS |
| Regulation Number | 868.5540 |
| Classification Product Code |
|
| Date Received | 04/25/1985 |
| Decision Date | 05/21/1985 |
| 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
|
|
|