The following data is part of a premarket notification filed by Contamac Ltd. with the FDA for Optimum Gp Ok Daily Wear Contact Lens (roflufocon D & E).
| Device ID | K160859 |
| 510k Number | K160859 |
| Device Name: | OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) |
| Classification | Lens, Contact (orthokeratology) |
| Applicant | CONTAMAC LTD. CARLTON HOUSE SHIRE HILL Saffron Walden, GB Cb11 3au |
| Contact | Rob Mcgregor |
| Correspondent | Bret Andre EYEREG CONSULTING, INC. 6119 CANTER LN West Linn, OR 97068 |
| Product Code | MUW |
| CFR Regulation Number | 886.5916 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-29 |
| Decision Date | 2016-07-13 |
| Summary: | summary |