The following data is part of a premarket notification filed by Exmoor Plastics Ltd. with the FDA for Causse Universal Ossicular Replacement Prosthesis (orp/1).
| Device ID | K963899 |
| 510k Number | K963899 |
| Device Name: | CAUSSE UNIVERSAL OSSICULAR REPLACEMENT PROSTHESIS (ORP/1) |
| Classification | Replacement, Ossicular Prosthesis, Total |
| 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 | ETA |
| CFR Regulation Number | 874.3495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-27 |
| Decision Date | 1997-08-22 |