| Device Classification Name |
Cuff, Tracheal Tube, Inflatable
|
| 510(k) Number |
K912723 |
| Device Name |
POSEY CUFFLATOR |
| Applicant |
| Posey Co. |
| 2443 Delta Ln. |
|
Elk Grove Village,
IL
60007
|
|
| Applicant Contact |
ERNEST M POSEY |
| Correspondent |
| Posey Co. |
| 2443 Delta Ln. |
|
Elk Grove Village,
IL
60007
|
|
| Correspondent Contact |
ERNEST M POSEY |
| Regulation Number | 868.5750 |
| Classification Product Code |
|
| Date Received | 06/19/1991 |
| Decision Date | 07/20/1991 |
| 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
|
|
|