The following data is part of a premarket notification filed by Jolife Ab with the FDA for Modification To Lucas.
| Device ID | K062401 |
| 510k Number | K062401 |
| Device Name: | MODIFICATION TO LUCAS |
| Classification | Compressor, Cardiac, External |
| Applicant | JOLIFE AB 555 13TH ST. NW Washington, DC 20004 |
| Contact | Howard M Holstein |
| Correspondent | Howard M Holstein JOLIFE AB 555 13TH ST. NW Washington, DC 20004 |
| Product Code | DRM |
| CFR Regulation Number | 870.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-16 |
| Decision Date | 2006-09-28 |
| Summary: | summary |