The following data is part of a premarket notification filed by Massachusetts Eye And Ear Infirmary D/b/a Boston with the FDA for Boston Keratoprosthesis, Type I Lucia.
| Device ID | K182986 |
| 510k Number | K182986 |
| Device Name: | Boston Keratoprosthesis, Type I Lucia |
| Classification | Keratoprosthesis, Permanent Implant |
| Applicant | Massachusetts Eye And Ear Infirmary D/b/a Boston Keratoprosthesis 243 Charles Street Boston, MA 02114 |
| Contact | James Chodosh |
| Correspondent | Kristy Katzenmeyer-pleuss Namsa Industrie Center Obernburg Obernburg Am Main, DE 63784 |
| Product Code | HQM |
| CFR Regulation Number | 886.3400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-29 |
| Decision Date | 2019-01-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00862395000214 | K182986 | 000 |