The following data is part of a premarket notification filed by Millennium Biomedical, Inc. with the FDA for Refractive Surgery Blades.
| Device ID | K001806 |
| 510k Number | K001806 |
| Device Name: | REFRACTIVE SURGERY BLADES |
| Classification | Keratome, Ac-powered |
| Applicant | MILLENNIUM BIOMEDICAL, INC. 360 EAST BONITA AVE. Pomona, CA 91767 |
| Contact | Jerry Kaeni |
| Correspondent | Jerry Kaeni MILLENNIUM BIOMEDICAL, INC. 360 EAST BONITA AVE. Pomona, CA 91767 |
| Product Code | HNO |
| CFR Regulation Number | 886.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-15 |
| Decision Date | 2000-09-12 |