The following data is part of a premarket notification filed by Contamac Ltd. with the FDA for Optimum Gp With Hpt (roflufocon A, B, C, D, And E) Daily Wear Contact Lenses.
| Device ID | K161100 |
| 510k Number | K161100 |
| Device Name: | Optimum GP With HPT (roflufocon A, B, C, D, And E) Daily Wear Contact Lenses |
| 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 | 2016-04-19 |
| Decision Date | 2016-08-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00865576000225 | K161100 | 000 |
| 00865576000218 | K161100 | 000 |
| 00865576000201 | K161100 | 000 |