The following data is part of a premarket notification filed by Academic Catalyst Corp. with the FDA for Stripe Projector.
| Device ID | K902138 |
| 510k Number | K902138 |
| Device Name: | STRIPE PROJECTOR |
| Classification | Lens, Fundus, Hruby, Diagnostic |
| Applicant | ACADEMIC CATALYST CORP. 14 MADISON AVE. Valhalla, NY 10595 |
| Contact | Lawrence Kunstadt |
| Correspondent | Lawrence Kunstadt ACADEMIC CATALYST CORP. 14 MADISON AVE. Valhalla, NY 10595 |
| Product Code | HJI |
| CFR Regulation Number | 886.1395 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-10 |
| Decision Date | 1990-07-05 |