The following data is part of a premarket notification filed by Contamac Ltd with the FDA for Contaflex 54 (hioxifilcon D) Spherical Soft Contact Lens For Daily Wear, Contaflex 49 (hioxifilcon B) Spherical Soft Contact Lens For Daily Wear,.
| Device ID | K150590 |
| 510k Number | K150590 |
| Device Name: | CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens For Daily Wear, CONTAFLEX 49 (hioxifilcon B) Spherical Soft Contact Lens For Daily Wear, |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | CONTAMAC LTD BEARWALDEN BUSINESS PARK Saffron Walden, GB Cb11 4jx |
| Contact | Rob Mcgregor |
| Correspondent | Bret Andre EyeReg Consulting, Inc. 474 NE 61st PL Hillsboro, OR 97124 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-09 |
| Decision Date | 2015-07-10 |
| Summary: | summary |