The following data is part of a premarket notification filed by Par Microsystems Corp. with the FDA for Corneal Topography System.
| Device ID | K923435 |
| 510k Number | K923435 |
| Device Name: | CORNEAL TOPOGRAPHY SYSTEM |
| Classification | Keratoscope, Ac-powered |
| Applicant | PAR MICROSYSTEMS CORP. 220 SENECA TURNPIKE New Hartford, NY 13413 |
| Contact | John Nabors |
| Correspondent | John Nabors PAR MICROSYSTEMS CORP. 220 SENECA TURNPIKE New Hartford, NY 13413 |
| Product Code | HLQ |
| CFR Regulation Number | 886.1350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-13 |
| Decision Date | 1993-02-16 |