The following data is part of a premarket notification filed by Argus Biomedical Pty Ltd with the FDA for Alphacor; Alphacor-a (for Ahakic Eyes); Alphacor-p (for Phakic Or Pseudophakic Eyes).
| Device ID | K013756 |
| 510k Number | K013756 |
| Device Name: | ALPHACOR; ALPHACOR-A (FOR AHAKIC EYES); ALPHACOR-P (FOR PHAKIC OR PSEUDOPHAKIC EYES) |
| Classification | Keratoprosthesis, Permanent Implant |
| Applicant | ARGUS BIOMEDICAL PTY LTD 3307 CLIFTON AVE., Cincinnati, OH 45220 |
| Contact | Barbara S Fant |
| Correspondent | Barbara S Fant ARGUS BIOMEDICAL PTY LTD 3307 CLIFTON AVE., Cincinnati, OH 45220 |
| Product Code | HQM |
| CFR Regulation Number | 886.3400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-13 |
| Decision Date | 2002-08-29 |
| Summary: | summary |