The following data is part of a premarket notification filed by Industrial & Medical Design, Inc. with the FDA for Millenium Microkeratome, Model Imd-001.
| Device ID | K992687 |
| 510k Number | K992687 |
| Device Name: | MILLENIUM MICROKERATOME, MODEL IMD-001 |
| Classification | Keratome, Battery-powered |
| Applicant | INDUSTRIAL & MEDICAL DESIGN, INC. 6230 WILSHIRE BLVD., SUITE 410 Los Angeles, CA 90048 |
| Contact | Yevgeniy Kuklin |
| Correspondent | Yevgeniy Kuklin INDUSTRIAL & MEDICAL DESIGN, INC. 6230 WILSHIRE BLVD., SUITE 410 Los Angeles, CA 90048 |
| Product Code | HMY |
| CFR Regulation Number | 886.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-10 |
| Decision Date | 1999-09-24 |
| Summary: | summary |