The following data is part of a premarket notification filed by Contamac Ltd. with the FDA for Optimum Gp (roflufocon A,b,c,d&e) Daily Wear Contact Lens..
| Device ID | K070628 |
| 510k Number | K070628 |
| Device Name: | OPTIMUM GP (ROFLUFOCON A,B,C,D&E) DAILY WEAR CONTACT LENS. |
| Classification | Lens, Contact (other Material) - Daily |
| Applicant | CONTAMAC LTD. 2214 SANFORD DRIVE,SUITE B7 Grand Junction, CO 81505 |
| Contact | Martin Dalsing |
| Correspondent | Martin Dalsing CONTAMAC LTD. 2214 SANFORD DRIVE,SUITE B7 Grand Junction, CO 81505 |
| Product Code | HQD |
| CFR Regulation Number | 886.5916 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-07 |
| Decision Date | 2007-05-01 |
| Summary: | summary |