The following data is part of a premarket notification filed by Hgm, Inc. with the FDA for Hgm, Inc. Medical Laser Endocoagulator Model 8-k.
| Device ID | K850572 |
| 510k Number | K850572 |
| Device Name: | HGM, INC. MEDICAL LASER ENDOCOAGULATOR MODEL 8-K |
| Classification | Laser, Ophthalmic |
| Applicant | HGM, INC. 3959 WEST 1820 SOUTH Salt Lake City, UT 84104 |
| Contact | Jerome Stenehjem |
| Correspondent | Jerome Stenehjem HGM, INC. 3959 WEST 1820 SOUTH Salt Lake City, UT 84104 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-13 |
| Decision Date | 1985-04-23 |