The following data is part of a premarket notification filed by Hgm, Inc. with the FDA for Model 8 & 20 Argon Laser For Pelvic Surgery In Gyn.
| Device ID | K862227 |
| 510k Number | K862227 |
| Device Name: | MODEL 8 & 20 ARGON LASER FOR PELVIC SURGERY IN GYN |
| Classification | Laser, Surgical, Gynecologic |
| Applicant | HGM, INC. 3959 WEST 1820 SOUTH Salt Lake City, UT 84104 |
| Contact | Landucci, M.d. |
| Correspondent | Landucci, M.d. HGM, INC. 3959 WEST 1820 SOUTH Salt Lake City, UT 84104 |
| Product Code | HHR |
| CFR Regulation Number | 884.4550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-11 |
| Decision Date | 1986-08-19 |