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 |