The following data is part of a premarket notification filed by Exmoor Plastics Ltd. with the FDA for Exmoor Aural Grommet Ag/t4.
| Device ID | K810705 |
| 510k Number | K810705 |
| Device Name: | EXMOOR AURAL GROMMET AG/T4 |
| Classification | Tube, Tympanostomy |
| Applicant | EXMOOR PLASTICS LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ETD |
| CFR Regulation Number | 874.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-03-16 |
| Decision Date | 1981-04-14 |