510(k) K915062
- Device
- DOHLMAN DOANE KERATOPROTHESIS
- Applicant
- MACKEEN CONSULTANTS, LTD.
- 510(k) number
- K915062
- Product code
- HQM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-01-21
- Date received
- 1991-11-08
- Regulation
- 886.3400
- Classification name
- Keratoprosthesis, Permanent Implant
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- DONALD L.MACKEEN
- Address
- 4903 Sangamore Rd. Bethesda MD US 20816 20816
FDA Registration Numbers#
- 3012483804
- 1047843
- 3010798453
- 1222945
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HQM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K182986 | Boston Keratoprosthesis, Type I Lucia | Massachusetts Eye and Ear Infirmary D/B/A Boston | 2019-01-30 |
| K121203 | BOSTON KERATOPROSTHESIS OR BOSTON KPRO | Massachusetts Eye & Ear Infirmary | 2013-05-10 |
| K013756 | ALPHACOR; ALPHACOR-A (FOR AHAKIC EYES); ALPHACOR-P (FOR PHAKIC OR PSEUDOPHAKIC EYES) | Argus Biomedical Pty, Ltd. | 2002-08-29 |
Legacy Summary#
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FDA Review#
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