The following data is part of a premarket notification filed by Polycore Optical Pte Ltd. with the FDA for Lens, Polycore.
| Device ID | K790215 |
| 510k Number | K790215 |
| Device Name: | LENS, POLYCORE |
| Classification | Lens, Spectacle, Non-custom (prescription) |
| Applicant | POLYCORE OPTICAL PTE LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HQG |
| CFR Regulation Number | 886.5844 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-01-30 |
| Decision Date | 1979-02-26 |