The following data is part of a premarket notification filed by Exmoor Plastics Ltd. with the FDA for Exmoor Bite Buffer.
| Device ID | K893006 |
| 510k Number | K893006 |
| Device Name: | EXMOOR BITE BUFFER |
| Classification | Bronchoscope (flexible Or Rigid) |
| 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 | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-24 |
| Decision Date | 1990-03-05 |