The following data is part of a premarket notification filed by Kera Corp. with the FDA for Model 2000 Intraoperative Corneascope.
| Device ID | K901009 |
| 510k Number | K901009 |
| Device Name: | MODEL 2000 INTRAOPERATIVE CORNEASCOPE |
| Classification | Keratoscope, Ac-powered |
| Applicant | KERA CORP. 1963 ROCK ST. SUITE #17 Mountain View, CA 94043 |
| Contact | Charles L Rose |
| Correspondent | Charles L Rose KERA CORP. 1963 ROCK ST. SUITE #17 Mountain View, CA 94043 |
| Product Code | HLQ |
| CFR Regulation Number | 886.1350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-05 |
| Decision Date | 1990-05-30 |