The following data is part of a premarket notification filed by Beta Optical Co, Inc. with the FDA for Ophthalmic Spectacle Lens Blanks.
| Device ID | K881225 |
| 510k Number | K881225 |
| Device Name: | OPHTHALMIC SPECTACLE LENS BLANKS |
| Classification | Lens, Spectacle, Non-custom (prescription) |
| Applicant | BETA OPTICAL CO, INC. 7041 SW 21 PLACE Davie, FL 33317 |
| Contact | James Magalhaes |
| Correspondent | James Magalhaes BETA OPTICAL CO, INC. 7041 SW 21 PLACE Davie, FL 33317 |
| Product Code | HQG |
| CFR Regulation Number | 886.5844 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-22 |
| Decision Date | 1988-04-19 |