The following data is part of a premarket notification filed by Beta Labs, Inc. with the FDA for Bl1 (hard Contact Lens).
| Device ID | K864343 |
| 510k Number | K864343 |
| Device Name: | BL1 (HARD CONTACT LENS) |
| Classification | Lens, Contact (polymethylmethacrylate) |
| Applicant | BETA LABS, INC. 42 PLEASANT ST. Stoneham, MA 02180 |
| Contact | Robert Painter |
| Correspondent | Robert Painter BETA LABS, INC. 42 PLEASANT ST. Stoneham, MA 02180 |
| Product Code | HPX |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-04 |
| Decision Date | 1986-11-28 |