The following data is part of a premarket notification filed by Mira, Inc. with the FDA for Intraocular Forceps & Scissors.
| Device ID | K854869 |
| 510k Number | K854869 |
| Device Name: | INTRAOCULAR FORCEPS & SCISSORS |
| Classification | Forceps, Ophthalmic |
| Applicant | MIRA, INC. 87 RUMFORD AVE. Waltham, MA 02453 -3846 |
| Contact | Mark W Furlong |
| Correspondent | Mark W Furlong MIRA, INC. 87 RUMFORD AVE. Waltham, MA 02453 -3846 |
| Product Code | HNR |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-04 |
| Decision Date | 1986-03-05 |