The following data is part of a premarket notification filed by Hgm Medical Laser Systems, Inc. with the FDA for Endocoagulator Model 20 Laser & Accessories.
| Device ID | K881507 |
| 510k Number | K881507 |
| Device Name: | ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIES |
| Classification | Laser, Surgical, Gynecologic |
| Applicant | HGM MEDICAL LASER SYSTEMS, INC. 3959 WEST 1820 SOUTH Salt Lake City, UT 84104 |
| Contact | R Mcarthur |
| Correspondent | R Mcarthur HGM MEDICAL LASER SYSTEMS, 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 | 1988-04-11 |
| Decision Date | 1989-04-27 |