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 |