The following data is part of a premarket notification filed by Paragon Vision Sciences with the FDA for Paflufocon A, B, C & D.
| Device ID | K940277 |
| 510k Number | K940277 |
| Device Name: | PAFLUFOCON A, B, C & D |
| Classification | Lens, Contact (other Material) - Daily |
| Applicant | PARAGON VISION SCIENCES 1100 EAST BELL RD. Phoenix, AZ 85022 |
| Contact | Duane Tracy |
| Correspondent | Duane Tracy PARAGON VISION SCIENCES 1100 EAST BELL RD. Phoenix, AZ 85022 |
| Product Code | HQD |
| CFR Regulation Number | 886.5916 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-19 |
| Decision Date | 1994-05-09 |