510(k) DEN150007
- Device
- Magnetic Surgical System
- Applicant
- Levita Magnetics International Corp
- 510(k) number
- DEN150007
- Product code
- PNL
- Decision
- Unknown (DENG)
- Decision date
- 2016-06-13
- Date received
- 2015-02-10
- Regulation
- 878.4815
- Classification name
- Magnetic Surgical System
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Cindy Domecus
- Address
- 1730 S.Amphlett Blvd., Suite 220 San Mateo CA US 94402 94402
FDA Registration Numbers#
- 2219920
- 3012986524
- 2953359
- 3008791915
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code PNL#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252435 | Magnetic Surgical System | Levita Magnetics International Corp | 2025-09-26 |
| K250746 | Magnetic Surgical System | Levita Magnetics International Corp | 2025-06-07 |
| K223673 | Surgeon Controlled Arm | Levita Magnetics International Corp | 2023-08-04 |
| K191762 | Magnetic Surgical System | Levita Magnetics International Corp | 2020-04-01 |
| K190006 | Magnetic Surgical System | Levita Magnetics International Corp | 2019-04-29 |
| K180894 | Magnetic Surgical System | Levita Magnetics International Corp | 2018-09-19 |
| K171429 | Magnetic Surgical System | Levita Magnetics International Corp | 2017-06-06 |