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 |