The following data is part of a premarket notification filed by Alliance Medical Marketinig with the FDA for Keratron Corneal Topographer.
| Device ID | K944616 |
| 510k Number | K944616 |
| Device Name: | KERATRON CORNEAL TOPOGRAPHER |
| Classification | Keratoscope, Ac-powered |
| Applicant | ALLIANCE MEDICAL MARKETINIG 3948 SOUTH THIRD ST. #282 Jacksonville Beach, FL 32250 |
| Contact | Scott Lewis |
| Correspondent | Scott Lewis ALLIANCE MEDICAL MARKETINIG 3948 SOUTH THIRD ST. #282 Jacksonville Beach, FL 32250 |
| Product Code | HLQ |
| CFR Regulation Number | 886.1350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-20 |
| Decision Date | 1994-11-22 |