The following data is part of a premarket notification filed by Exmoor Plastics Ltd. with the FDA for Exmoor Single Use Myringotomes.
| Device ID | K942745 |
| 510k Number | K942745 |
| Device Name: | EXMOOR SINGLE USE MYRINGOTOMES |
| Classification | Instrument, Ent Manual Surgical |
| 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 | LRC |
| CFR Regulation Number | 874.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-10 |
| Decision Date | 1994-09-02 |