The following data is part of a premarket notification filed by Hgm Medical Laser Systems, Inc. with the FDA for 5 Mm Irrigation/aspiration Fiber Probe.
| Device ID | K902258 |
| 510k Number | K902258 |
| Device Name: | 5 MM IRRIGATION/ASPIRATION FIBER PROBE |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | HGM MEDICAL LASER SYSTEMS, INC. 3959 WEST 1820 SOUTH Salt Lake City, UT 84104 |
| Contact | Dennis Reigle |
| Correspondent | Dennis Reigle HGM MEDICAL LASER SYSTEMS, INC. 3959 WEST 1820 SOUTH Salt Lake City, UT 84104 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-21 |
| Decision Date | 1990-09-19 |