The following data is part of a premarket notification filed by Hgm, Inc. with the FDA for Medical Laser Endocoagulator 5k.
| Device ID | K840854 |
| 510k Number | K840854 |
| Device Name: | MEDICAL LASER ENDOCOAGULATOR 5K |
| Classification | Laser, Ophthalmic |
| Applicant | HGM, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-24 |
| Decision Date | 1984-04-02 |