The following data is part of a premarket notification filed by Contamac Ltd. with the FDA for Optimum Hr-1.51 (hiflufocon A) And Hr-1.53 (hiflufocon B) Daily Wear Contact Lenses.
| Device ID | K081178 |
| 510k Number | K081178 |
| Device Name: | OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LENSES |
| Classification | Lens, Contact (other Material) - Daily |
| Applicant | CONTAMAC LTD. 806 KIMBALL AVENUE Grand Junction, CO 81501 |
| Contact | Martin Dalsing |
| Correspondent | Martin Dalsing CONTAMAC LTD. 806 KIMBALL AVENUE Grand Junction, CO 81501 |
| Product Code | HQD |
| CFR Regulation Number | 886.5916 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-25 |
| Decision Date | 2008-10-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00865576000256 | K081178 | 000 |
| 00865576000249 | K081178 | 000 |