The following data is part of a premarket notification filed by Mackeen Consultants, Ltd. with the FDA for Dohlman Doane Keratoprothesis.
Device ID | K915062 |
510k Number | K915062 |
Device Name: | DOHLMAN DOANE KERATOPROTHESIS |
Classification | Keratoprosthesis, Permanent Implant |
Applicant | MACKEEN CONSULTANTS, LTD. 4903 SANGAMORE RD. Bethesda, MD 20816 |
Contact | Donald L.mackeen |
Correspondent | Donald L.mackeen MACKEEN CONSULTANTS, LTD. 4903 SANGAMORE RD. Bethesda, MD 20816 |
Product Code | HQM |
CFR Regulation Number | 886.3400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-11-08 |
Decision Date | 1992-01-21 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00862394000260 | K915062 | 000 |
00862394000239 | K915062 | 000 |
00862394000222 | K915062 | 000 |
00862394000215 | K915062 | 000 |
00862394000208 | K915062 | 000 |