K963899 is an FDA 510(k) clearance for the CAUSSE UNIVERSAL OSSICULAR REPLACEMENT PROSTHESIS (ORP/1). This device is classified as a Replacement, Ossicular Prosthesis, Total (Class II - Special Controls, product code ETA).
Submitted by Exmoor Plastics , Ltd. (Taunton, GB). The FDA issued a Cleared decision on August 22, 1997, 329 days after receiving the submission on September 27, 1996.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3495.
| 510(k) Number | K963899 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 1996 |
| Decision Date | August 22, 1997 |
| Days to Decision | 329 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Statement |
| Product Code | ETA — Replacement, Ossicular Prosthesis, Total |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3495 |