K003567 is an FDA 510(k) clearance for the SERENOCEM, MODEL BC 010. This device is classified as a Cement, Ear, Nose And Throat (Class II - Special Controls, product code NEA).
Submitted by Corinthian Medical , Ltd. (Amsterdam, NL). The FDA issued a Cleared decision on February 12, 2001, 84 days after receiving the submission on November 20, 2000.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 872.3275.
| 510(k) Number | K003567 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 20, 2000 |
| Decision Date | February 12, 2001 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | NEA — Cement, Ear, Nose And Throat |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3275 |