The following data is part of a premarket notification filed by Del Mar Technologies, Inc. with the FDA for Medart 455 Scanner System.
| Device ID | K984339 |
| 510k Number | K984339 |
| Device Name: | MEDART 455 SCANNER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | DEL MAR TECHNOLOGIES, INC. 11772 SORRENTO VALLEY RD. SUITE #240 San Diego, CA 92121 |
| Contact | Jan K Enemaerk |
| Correspondent | Jan K Enemaerk DEL MAR TECHNOLOGIES, INC. 11772 SORRENTO VALLEY RD. SUITE #240 San Diego, CA 92121 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-04 |
| Decision Date | 1999-02-18 |