The following data is part of a premarket notification filed by Unimedix, Inc. with the FDA for Unimedix Holmium Fiber.
| Device ID | K924424 |
| 510k Number | K924424 |
| Device Name: | UNIMEDIX HOLMIUM FIBER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | UNIMEDIX, INC. 20 DRUM HILL DR. Summit, NJ 07901 |
| Contact | Raymond R Blanche |
| Correspondent | Raymond R Blanche UNIMEDIX, INC. 20 DRUM HILL DR. Summit, NJ 07901 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-01 |
| Decision Date | 1993-04-23 |