The following data is part of a premarket notification filed by Alcon Laboratories with the FDA for Tbd Keratoscope.
| Device ID | K912130 |
| 510k Number | K912130 |
| Device Name: | TBD KERATOSCOPE |
| Classification | Keratoscope, Ac-powered |
| Applicant | ALCON LABORATORIES 6201 SOUTH FREEWAY R7-14 Fort Worth, TX 76134 -2099 |
| Contact | David Krapf |
| Correspondent | David Krapf ALCON LABORATORIES 6201 SOUTH FREEWAY R7-14 Fort Worth, TX 76134 -2099 |
| Product Code | HLQ |
| CFR Regulation Number | 886.1350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-14 |
| Decision Date | 1991-08-09 |