K962693 is an FDA 510(k) clearance for the MONTGOMERY RADIOPAQUE LARYNGEAL KEEL. This device is classified as a Prosthesis, Larynx (stents And Keels) (Class II - Special Controls, product code FWN).
Submitted by Boston Medical Products, Inc. (Westborough, US). The FDA issued a Cleared decision on August 9, 1996, 29 days after receiving the submission on July 11, 1996.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3620.
| 510(k) Number | K962693 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 11, 1996 |
| Decision Date | August 09, 1996 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | FWN — Prosthesis, Larynx (stents And Keels) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3620 |