The following data is part of a premarket notification filed by Essilor Intl. with the FDA for Rythmic And Rythmic Uv.
| Device ID | K003170 |
| 510k Number | K003170 |
| Device Name: | RYTHMIC AND RYTHMIC UV |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | ESSILOR INTL. CLIFTON HOUSE BRUNEL WAY SEGENSWORTH EAST, FAREHAM Hampshire, GB Po15 5tx |
| Contact | Christine Moench |
| Correspondent | Christine Moench ESSILOR INTL. CLIFTON HOUSE BRUNEL WAY SEGENSWORTH EAST, FAREHAM Hampshire, GB Po15 5tx |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-10 |
| Decision Date | 2000-12-15 |