| DeNovo ID | DEN150007 |
| Device Name: | Magnetic Surgical System |
| Classification | Magnetic Surgical System |
| Applicant | Levita Magnetics International Corp. 1730 S.amphlett Blvd, Ste 220 San Mateo, CA 94402 |
| Contact | Cindy Domecus |
| Product Code | PNL |
| CFR Regulation Number | 878.4815 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | General & Plastic Surgery |
| Classification Advisory | General & Plastic Surgery |
| Type | Direct |
| Date Received | 2015-02-10 |
| Decision Date | 2016-06-13 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |