The following data is part of a premarket notification filed by Optical Micro Systems, Inc. with the FDA for Oms Silicone Oil Injector.
| Device ID | K844895 |
| 510k Number | K844895 |
| Device Name: | OMS SILICONE OIL INJECTOR |
| Classification | Fluid, Intraocular |
| Applicant | OPTICAL MICRO SYSTEMS, INC. 8 ELECTRONICS AVE. Danvers, MA 01923 |
| Contact | Gerald A Clay |
| Correspondent | Gerald A Clay OPTICAL MICRO SYSTEMS, INC. 8 ELECTRONICS AVE. Danvers, MA 01923 |
| Product Code | LWL |
| CFR Regulation Number | 886.4275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-17 |
| Decision Date | 1985-06-24 |