The following data is part of a premarket notification filed by Mira, Inc. with the FDA for Modification Of Anterior Segment Electrodes.
| Device ID | K933527 |
| 510k Number | K933527 |
| Device Name: | MODIFICATION OF ANTERIOR SEGMENT ELECTRODES |
| Classification | Impactor |
| Applicant | MIRA, INC. 87 RUMFORD AVE. Waltham, MA 02453 -3846 |
| Contact | Roger R O'brien |
| Correspondent | Roger R O'brien MIRA, INC. 87 RUMFORD AVE. Waltham, MA 02453 -3846 |
| Product Code | HWA |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-20 |
| Decision Date | 1994-01-25 |