The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Gore Revox Thyroplasty Implant.
| Device ID | K983525 |
| 510k Number | K983525 |
| Device Name: | GORE REVOX THYROPLASTY IMPLANT |
| Classification | System, Vocal Cord Medialization |
| Applicant | W.L. GORE & ASSOCIATES,INC 301 AIRPORT RD Elkton, MD 21922 -1408 |
| Contact | John Nicholson |
| Correspondent | John Nicholson W.L. GORE & ASSOCIATES,INC 301 AIRPORT RD Elkton, MD 21922 -1408 |
| Product Code | MIX |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-08 |
| Decision Date | 1998-12-10 |
| Summary: | summary |