The following data is part of a premarket notification filed by Omnivision Ag with the FDA for Maxitears Contacts Pf.
| Device ID | K182984 |
| 510k Number | K182984 |
| Device Name: | MaxiTears Contacts PF |
| Classification | Products, Contact Lens Care, Rigid Gas Permeable |
| Applicant | Omnivision AG Zentralstr. 100 Neuhausen Am Rheinfall, CH Ch-8212 |
| Contact | Joachim Kolter |
| Correspondent | Oliver Eikenberg Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746 |
| Product Code | MRC |
| CFR Regulation Number | 886.5918 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-29 |
| Decision Date | 2019-07-24 |
| Summary: | summary |