| Device Classification Name |
Airway, Oropharyngeal, Anesthesiology
|
| 510(k) Number |
K844873 |
| Device Name |
PENNINE GUEDEL AIRWAY 00,0,1,2,3 & 4 |
| Applicant |
| Pennine Medical , Ltd. |
| Pontefract St.Ascot |
| Dr.Ind.Esate |
|
Derby,
GB
|
|
| Applicant Contact |
TERRY MORGAN |
| Correspondent |
| Pennine Medical , Ltd. |
| Pontefract St.Ascot |
| Dr.Ind.Esate |
|
Derby,
GB
|
|
| Correspondent Contact |
TERRY MORGAN |
| Regulation Number | 868.5110 |
| Classification Product Code |
|
| Date Received | 12/17/1984 |
| Decision Date | 02/21/1985 |
| 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
|
|
|