| Device Classification Name |
Laryngoscope, Rigid
|
| 510(k) Number |
K901680 |
| Device Name |
BAUMAN RIGID LARYNGOSCOPE |
| Applicant |
| Palex Intl. SA |
| Carretera De Terrassa, 121 |
| 08191 Rubi' (Barcelona) |
|
Spain,
ES
|
|
| Applicant Contact |
MARTIN A JORDAN |
| Correspondent |
| Palex Intl. SA |
| Carretera De Terrassa, 121 |
| 08191 Rubi' (Barcelona) |
|
Spain,
ES
|
|
| Correspondent Contact |
MARTIN A JORDAN |
| Regulation Number | 868.5540 |
| Classification Product Code |
|
| Date Received | 04/12/1990 |
| Decision Date | 07/12/1990 |
| 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
|
|
|