The following data is part of a premarket notification filed by Hgm Medical Laser Systems, Inc. with the FDA for O-020 Laser Indirect Ophthalmoscope.
| Device ID | K890787 |
| 510k Number | K890787 |
| Device Name: | O-020 LASER INDIRECT OPHTHALMOSCOPE |
| Classification | Source, Abortion Unit, Vacuum |
| Applicant | HGM MEDICAL LASER SYSTEMS, INC. 3959 WEST 1820 SOUTH Salt Lake City, UT 84104 |
| Contact | Bill Papworth |
| Correspondent | Bill Papworth HGM MEDICAL LASER SYSTEMS, INC. 3959 WEST 1820 SOUTH Salt Lake City, UT 84104 |
| Product Code | HGF |
| CFR Regulation Number | 884.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-15 |
| Decision Date | 1989-03-24 |