The following data is part of a premarket notification filed by Levita Magnetics International Corp. with the FDA for Magnetic Surgical System.
| Device ID | K190006 |
| 510k Number | K190006 |
| Device Name: | Magnetic Surgical System |
| Classification | Magnetic Surgical System |
| Applicant | Levita Magnetics International Corp. 1730 S. Amphlett Blvd, Suite 240 San Mateo, CA 94402 |
| Contact | Alberto Rodrigues-navarro |
| Correspondent | Cindy Domecus Domecus Consulting Services LLC 1171 Barroilhet Drive Hillsborough, CA 94010 |
| Product Code | PNL |
| CFR Regulation Number | 878.4815 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-02 |
| Decision Date | 2019-04-29 |