The following data is part of a premarket notification filed by Exmoor Plastics Ltd. with the FDA for Mills Incus Ha Sleeve.
| Device ID | K974365 |
| 510k Number | K974365 |
| Device Name: | MILLS INCUS HA SLEEVE |
| Classification | Prosthesis, Partial Ossicular Replacement |
| Applicant | EXMOOR PLASTICS LTD. LISIEUX WAY Taunton, GB Ta1 2lb |
| Contact | Margaret Blackmore |
| Correspondent | Margaret Blackmore EXMOOR PLASTICS LTD. LISIEUX WAY Taunton, GB Ta1 2lb |
| Product Code | ETB |
| CFR Regulation Number | 874.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-19 |
| Decision Date | 1998-01-22 |
| Summary: | summary |