K945107 is an FDA 510(k) clearance for the POLY-WIRE PISTON. This device is classified as a Prosthesis, Partial Ossicular Replacement (Class II - Special Controls, product code ETB).
Submitted by Micromed Development Corp. (Clearwater, US). The FDA issued a Cleared decision on November 22, 1994, 35 days after receiving the submission on October 18, 1994.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3450.
| 510(k) Number | K945107 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 18, 1994 |
| Decision Date | November 22, 1994 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | ETB — Prosthesis, Partial Ossicular Replacement |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3450 |