Device Classification Name |
Keratoprosthesis, Permanent Implant
|
510(k) Number |
K013756 |
Device Name |
ALPHACOR; ALPHACOR-A (FOR AHAKIC EYES); ALPHACOR-P (FOR PHAKIC OR PSEUDOPHAKIC EYES) |
Applicant |
ARGUS BIOMEDICAL PTY LTD |
3307 CLIFTON AVE., |
CINCINNATI,
OH
45220
|
|
Applicant Contact |
BARBARA S FANT |
Correspondent |
ARGUS BIOMEDICAL PTY LTD |
3307 CLIFTON AVE., |
CINCINNATI,
OH
45220
|
|
Correspondent Contact |
BARBARA S FANT |
Regulation Number | 886.3400
|
Classification Product Code |
|
Date Received | 11/13/2001 |
Decision Date | 08/29/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|