The following data is part of a premarket notification filed by Mira, Inc. with the FDA for Converter System.
| Device ID | K894248 |
| 510k Number | K894248 |
| Device Name: | CONVERTER SYSTEM |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Applicant | MIRA, INC. 87 RUMFORD AVE. Waltham, MA 02453 -3846 |
| Contact | Roger O'brien |
| Correspondent | Roger O'brien MIRA, INC. 87 RUMFORD AVE. Waltham, MA 02453 -3846 |
| Product Code | HQE |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-21 |
| Decision Date | 1990-02-27 |