The following data is part of a premarket notification filed by Inmed Corp. with the FDA for Disposable Guedel Airway.
| Device ID | K850248 |
| 510k Number | K850248 |
| Device Name: | DISPOSABLE GUEDEL AIRWAY |
| Classification | Airway, Oropharyngeal, Anesthesiology |
| Applicant | INMED CORP. 3030-B HOLCOMB BRIDGE RD. Norcross, GA 30071 |
| Contact | Flo Becker |
| Correspondent | Flo Becker INMED CORP. 3030-B HOLCOMB BRIDGE RD. Norcross, GA 30071 |
| Product Code | CAE |
| CFR Regulation Number | 868.5110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-22 |
| Decision Date | 1985-03-12 |