510(k) K013756
- Device
- ALPHACOR; ALPHACOR-A (FOR AHAKIC EYES); ALPHACOR-P (FOR PHAKIC OR PSEUDOPHAKIC EYES)
- Applicant
- ARGUS BIOMEDICAL PTY LTD
- 510(k) number
- K013756
- Product code
- HQM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-08-29
- Date received
- 2001-11-13
- Regulation
- 886.3400
- Classification name
- Keratoprosthesis, Permanent Implant
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- BARBARA S FANT
- Address
- 3307 Clifton Ave. Cincinnati OH US 45220 45220
FDA Registration Numbers#
- 3012483804
- 1047843
- 3010798453
- 1222945
Source Documents#
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 |
| K915062 | DOHLMAN DOANE KERATOPROTHESIS | Mackeen Consultants, Ltd. | 1992-01-21 |
Legacy Summary#
summary
FDA Review#
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