The following data is part of a premarket notification filed by Contamac Ltd. with the FDA for Hybrid Fs & Hybrid Fs Toric (hycofocon A) Rgp Contact Lens For Daily Wear.
| Device ID | K021977 |
| 510k Number | K021977 |
| Device Name: | HYBRID FS & HYBRID FS TORIC (HYCOFOCON A) RGP CONTACT LENS FOR DAILY WEAR |
| Classification | Lens, Contact (other Material) - Daily |
| Applicant | CONTAMAC LTD. 13 RED FOX LN. Littleton, CO 80127 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls CONTAMAC LTD. 13 RED FOX LN. Littleton, CO 80127 |
| Product Code | HQD |
| CFR Regulation Number | 886.5916 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-17 |
| Decision Date | 2002-09-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00865576000270 | K021977 | 000 |