The following data is part of a premarket notification filed by Dynarex Corp. with the FDA for Oral Airway.
| Device ID | K891586 |
| 510k Number | K891586 |
| Device Name: | ORAL AIRWAY |
| Classification | Airway, Oropharyngeal, Anesthesiology |
| Applicant | DYNAREX CORP. ONE INTERNATIONAL BLVD. Brewster, NY 10509 |
| Contact | Marvin D Schattner |
| Correspondent | Marvin D Schattner DYNAREX CORP. ONE INTERNATIONAL BLVD. Brewster, NY 10509 |
| Product Code | CAE |
| CFR Regulation Number | 868.5110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-20 |
| Decision Date | 1989-05-11 |