The following data is part of a premarket notification filed by Contamac Ltd. with the FDA for Modification To Optimum Gp (oxygen Permeable) Daily Wear Contact Lenses.
| Device ID | K062548 |
| 510k Number | K062548 |
| Device Name: | MODIFICATION TO OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES |
| Classification | Lens, Contact (other Material) - Daily |
| Applicant | CONTAMAC LTD. 2214 SANFORD DRIVE UNIT B7 Grand Junction, CO 81505 |
| Contact | Martin Dalsing |
| Correspondent | Martin Dalsing CONTAMAC LTD. 2214 SANFORD DRIVE UNIT B7 Grand Junction, CO 81505 |
| Product Code | HQD |
| CFR Regulation Number | 886.5916 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-30 |
| Decision Date | 2006-11-01 |
| Summary: | summary |