K961124 is an FDA 510(k) clearance for the THE NAUTILUS. This device is classified as a Prosthesis, Nose, Internal (Class II - Special Controls, product code FZE).
Submitted by Rand Scientific Corp. (Sacramento, US). The FDA issued a Cleared decision on April 19, 1996, 29 days after receiving the submission on March 21, 1996.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3680.
| 510(k) Number | K961124 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 21, 1996 |
| Decision Date | April 19, 1996 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | FZE — Prosthesis, Nose, Internal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3680 |