The following data is part of a premarket notification filed by Contamac Ltd. with the FDA for Optimum Gp (oxygen Permeable) Daily Wear Contact Lenses.
| Device ID | K033594 |
| 510k Number | K033594 |
| Device Name: | OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES |
| Classification | Lens, Contact (other Material) - Daily |
| Applicant | CONTAMAC LTD. 623 GLACIER DR. Grand Junction, CO 81503 |
| Contact | Martin Dalsing |
| Correspondent | Martin Dalsing CONTAMAC LTD. 623 GLACIER DR. Grand Junction, CO 81503 |
| Product Code | HQD |
| CFR Regulation Number | 886.5916 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-13 |
| Decision Date | 2004-03-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00865576000232 | K033594 | 000 |
| 00865576000225 | K033594 | 000 |
| 00865576000218 | K033594 | 000 |
| 00865576000201 | K033594 | 000 |