The following data is part of a premarket notification filed by Koi, Inc. with the FDA for Blade Gauge.
| Device ID | K812011 |
| 510k Number | K812011 |
| Device Name: | BLADE GAUGE |
| Classification | Caliper, Ophthalmic |
| Applicant | KOI, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HOE |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-07-17 |
| Decision Date | 1981-07-28 |