The following data is part of a premarket notification filed by Scieran Technologies, Inc. with the FDA for Vit Commander System.
| Device ID | K961738 |
| 510k Number | K961738 |
| Device Name: | VIT COMMANDER SYSTEM |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Applicant | SCIERAN TECHNOLOGIES, INC. 27071 CABOT RD., SUITE 127 Laguna Hills, CA 92653 |
| Contact | Rod Ross |
| Correspondent | Rod Ross SCIERAN TECHNOLOGIES, INC. 27071 CABOT RD., SUITE 127 Laguna Hills, CA 92653 |
| Product Code | HQE |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-03 |
| Decision Date | 1996-11-25 |