K896667 is an FDA 510(k) clearance for the LORENZ STENT. This device is classified as a Prosthesis, Larynx (stents And Keels) (Class II - Special Controls, product code FWN).
Submitted by Walter Lorenz Surgical, Inc. (Jacksonville, US). The FDA issued a Cleared decision on February 22, 1990, 87 days after receiving the submission on November 27, 1989.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3620.
| 510(k) Number | K896667 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 27, 1989 |
| Decision Date | February 22, 1990 |
| Days to Decision | 87 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 |