The following data is part of a premarket notification filed by Contamac Ltd. with the FDA for Hyper Gp (tisilfocon A) Daily Wear Contact Lens.
| Device ID | K182304 |
| 510k Number | K182304 |
| Device Name: | Hyper GP (tisilfocon A) Daily Wear Contact Lens |
| Classification | Lens, Contact (other Material) - Daily |
| 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 | HQD |
| CFR Regulation Number | 886.5916 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-24 |
| Decision Date | 2018-11-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00865576000294 | K182304 | 000 |