K884810 is an FDA 510(k) clearance for the SILICONE LARYNGEAL STENT. This device is classified as a Prosthesis, Larynx (stents And Keels) (Class II - Special Controls, product code FWN).
Submitted by Hood Laboratories (Pembroke, US). The FDA issued a Cleared decision on May 10, 1989, 174 days after receiving the submission on November 17, 1988.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3620.
| 510(k) Number | K884810 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 17, 1988 |
| Decision Date | May 10, 1989 |
| Days to Decision | 174 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | — |
| Product Code | FWN — Prosthesis, Larynx (stents And Keels) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3620 |