The following data is part of a premarket notification filed by Mira, Inc. with the FDA for Ophthalmic Trichiasis Probe.
| Device ID | K923629 |
| 510k Number | K923629 |
| Device Name: | OPHTHALMIC TRICHIASIS PROBE |
| Classification | Unit, Cryophthalmic |
| 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 | HPS |
| CFR Regulation Number | 886.4170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-21 |
| Decision Date | 1992-10-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850510007597 | K923629 | 000 |