The following data is part of a premarket notification filed by Vistek Corp. with the FDA for Lca 2000.
| Device ID | K871034 |
| 510k Number | K871034 |
| Device Name: | LCA 2000 |
| Classification | Light, Surgical, Accessories |
| Applicant | VISTEK CORP. 4 EAST YANONALI ST. Santa Barbara, CA 93101 |
| Contact | John M Gibbons |
| Correspondent | John M Gibbons VISTEK CORP. 4 EAST YANONALI ST. Santa Barbara, CA 93101 |
| Product Code | FTA |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-17 |
| Decision Date | 1987-04-10 |