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 |