The following data is part of a premarket notification filed by Numedis, Inc. with the FDA for Life4c.
| Device ID | K063304 |
| 510k Number | K063304 |
| Device Name: | LIFE4C |
| Classification | Media, Corneal Storage |
| Applicant | NUMEDIS, INC. 188 BUMSTEAD RD. Monson, MA 01057 |
| Contact | Mary E Freddo |
| Correspondent | Mary E Freddo NUMEDIS, INC. 188 BUMSTEAD RD. Monson, MA 01057 |
| Product Code | LYX |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-01 |
| Decision Date | 2007-12-21 |
| Summary: | summary |