The following data is part of a premarket notification filed by Accutome, Inc. with the FDA for Kremer Blade Gauge.
| Device ID | K820050 |
| 510k Number | K820050 |
| Device Name: | KREMER BLADE GAUGE |
| Classification | Caliper, Ophthalmic |
| Applicant | ACCUTOME, 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 | 1982-01-08 |
| Decision Date | 1982-02-24 |