The following data is part of a premarket notification filed by Exmoor Plastics Ltd. with the FDA for Bel-air Ventilation Tube.
| Device ID | K926462 |
| 510k Number | K926462 |
| Device Name: | BEL-AIR VENTILATION TUBE |
| Classification | Tube, Tympanostomy |
| Applicant | EXMOOR PLASTICS LTD. LISIEUX WAY Taunton, Somerset, GB Ta1 2lb |
| Contact | Brian East |
| Correspondent | Brian East EXMOOR PLASTICS LTD. LISIEUX WAY Taunton, Somerset, GB Ta1 2lb |
| Product Code | ETD |
| CFR Regulation Number | 874.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-24 |
| Decision Date | 1993-05-05 |