The following data is part of a premarket notification filed by Intavent Intl. S.a. with the FDA for Intavent Laryngeal Mask.
| Device ID | K904834 |
| 510k Number | K904834 |
| Device Name: | INTAVENT LARYNGEAL MASK |
| Classification | Airway, Oropharyngeal, Anesthesiology |
| Applicant | INTAVENT INTL. S.A. ST. ANDREWS, ABNEY CT DR. BOURNE END, BUCKS SL8 5DL England, GB |
| Contact | Brain |
| Correspondent | Brain INTAVENT INTL. S.A. ST. ANDREWS, ABNEY CT DR. BOURNE END, BUCKS SL8 5DL England, GB |
| Product Code | CAE |
| CFR Regulation Number | 868.5110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-24 |
| Decision Date | 1991-07-26 |