The following data is part of a premarket notification filed by Massachusetts Eye & Ear Infirmary with the FDA for Boston Keratoprosthesis Or Boston Kpro.
| Device ID | K121203 |
| 510k Number | K121203 |
| Device Name: | BOSTON KERATOPROSTHESIS OR BOSTON KPRO |
| Classification | Keratoprosthesis, Permanent Implant |
| Applicant | MASSACHUSETTS EYE & EAR INFIRMARY 49 PLAIN STREET North Attleboro, MA 02760 |
| Contact | Brian J Edwards |
| Correspondent | Brian J Edwards MASSACHUSETTS EYE & EAR INFIRMARY 49 PLAIN STREET North Attleboro, MA 02760 |
| Product Code | HQM |
| CFR Regulation Number | 886.3400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-20 |
| Decision Date | 2013-05-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00862395000207 | K121203 | 000 |
| 00862394000291 | K121203 | 000 |
| 00862394000284 | K121203 | 000 |
| 00862394000277 | K121203 | 000 |
| 00862394000253 | K121203 | 000 |
| 00862394000246 | K121203 | 000 |