The following data is part of a premarket notification filed by Hgm Medical Laser Systems, Inc. with the FDA for Endocoagulator Krs568(tm) Laser.
| Device ID | K904700 |
| 510k Number | K904700 |
| Device Name: | ENDOCOAGULATOR KRS568(TM) LASER |
| Classification | Powered Laser Surgical Instrument |
| 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 | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-16 |
| Decision Date | 1991-02-19 |