The following data is part of a premarket notification filed by Exmoor Plastics Ltd. with the FDA for Mills Columella Prosthesis.
| Device ID | K981088 |
| 510k Number | K981088 |
| Device Name: | MILLS COLUMELLA PROSTHESIS |
| Classification | Replacement, Ossicular Prosthesis, Total |
| Applicant | EXMOOR PLASTICS LTD. LISIEUX WAY Taunton, GB Ta1 2lb |
| Contact | Margaret Blackemore |
| Correspondent | Margaret Blackemore EXMOOR PLASTICS LTD. LISIEUX WAY Taunton, GB Ta1 2lb |
| Product Code | ETA |
| CFR Regulation Number | 874.3495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-25 |
| Decision Date | 1998-06-05 |
| Summary: | summary |