The following data is part of a premarket notification filed by Medart A/s with the FDA for Medart 620.
| Device ID | K120573 |
| 510k Number | K120573 |
| Device Name: | MEDART 620 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | MEDART A/S 2, PARK PAVILIONS, CLOS LLYN CWM, ENTERPRISE PARK Swansea, GB Sa6 8qy |
| Contact | Darren Thomas |
| Correspondent | Darren Thomas MEDART A/S 2, PARK PAVILIONS, CLOS LLYN CWM, ENTERPRISE PARK Swansea, GB Sa6 8qy |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-27 |
| Decision Date | 2012-06-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05700002070609 | K120573 | 000 |