The following data is part of a premarket notification filed by Ote North America Llc with the FDA for Ote Mps 045 Multi-purpose Lens Care Solution.
| Device ID | K210051 |
| 510k Number | K210051 |
| Device Name: | OTE MPS 045 Multi-purpose Lens Care Solution |
| Classification | Accessories, Soft Lens Products |
| Applicant | OTE North America LLC 40 Bayview Ave Inwood, NY 11096 |
| Contact | Nathan Rosenberg |
| Correspondent | Ellen M. Beucler Foresight Regulatory Strategies, Inc. 1820 Turnpike Street, Suite 201 North Andover, MA 01845 |
| Product Code | LPN |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-08 |
| Decision Date | 2021-05-26 |