The following data is part of a premarket notification filed by Optical Micro Systems, Inc. with the FDA for Visc-x Vitreous Aspirating & Cutting Instrument Sy.
| Device ID | K844715 |
| 510k Number | K844715 |
| Device Name: | VISC-X VITREOUS ASPIRATING & CUTTING INSTRUMENT SY |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Applicant | OPTICAL MICRO SYSTEMS, INC. 8 ELECTRONICS AVE. Danvers, MA 01923 |
| Contact | Wayne A Richard |
| Correspondent | Wayne A Richard OPTICAL MICRO SYSTEMS, INC. 8 ELECTRONICS AVE. Danvers, MA 01923 |
| Product Code | HQE |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-27 |
| Decision Date | 1985-01-22 |