The following data is part of a premarket notification filed by Innovision Medical, Inc. with the FDA for Ocular Connection Machine(tm).
| Device ID | K890133 |
| 510k Number | K890133 |
| Device Name: | OCULAR CONNECTION MACHINE(TM) |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Applicant | INNOVISION MEDICAL, INC. 2532 WHITE RD. Irvine, CA 92714 |
| Contact | Gustavus D Bock |
| Correspondent | Gustavus D Bock INNOVISION MEDICAL, INC. 2532 WHITE RD. Irvine, CA 92714 |
| Product Code | HQE |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-12 |
| Decision Date | 1989-04-12 |