The following data is part of a premarket notification filed by Oem Medical Div. with the FDA for Guedel Airway.
| Device ID | K922748 |
| 510k Number | K922748 |
| Device Name: | GUEDEL AIRWAY |
| Classification | Airway, Oropharyngeal, Anesthesiology |
| Applicant | OEM MEDICAL DIV. 8741 LANDMARK RD. P.O. BOX 27604 Richmond, VA 23228 |
| Contact | Jerry W.scheib |
| Correspondent | Jerry W.scheib OEM MEDICAL DIV. 8741 LANDMARK RD. P.O. BOX 27604 Richmond, VA 23228 |
| Product Code | CAE |
| CFR Regulation Number | 868.5110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-08 |
| Decision Date | 1992-07-10 |