The following data is part of a premarket notification filed by Pennine Medical Ltd. with the FDA for Pennine Guedel Airway 00,0,1,2,3 & 4.
| Device ID | K844873 |
| 510k Number | K844873 |
| Device Name: | PENNINE GUEDEL AIRWAY 00,0,1,2,3 & 4 |
| Classification | Airway, Oropharyngeal, Anesthesiology |
| Applicant | PENNINE MEDICAL LTD. PONTEFRACT ST.ASCOT DR.IND.ESATE Derby, GB |
| Contact | Terry Morgan |
| Correspondent | Terry Morgan PENNINE MEDICAL LTD. PONTEFRACT ST.ASCOT DR.IND.ESATE Derby, GB |
| Product Code | CAE |
| CFR Regulation Number | 868.5110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-17 |
| Decision Date | 1985-02-21 |