The following data is part of a premarket notification filed by Trimedyne, Inc. with the FDA for Trimedyne Medical Argon Laser System Model 700.
| Device ID | K851405 |
| 510k Number | K851405 |
| Device Name: | TRIMEDYNE MEDICAL ARGON LASER SYSTEM MODEL 700 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | TRIMEDYNE, INC. 1815 EAST CARNEGIE AVE. Santa Ana, CA 92705 |
| Contact | Hany Hussein |
| Correspondent | Hany Hussein TRIMEDYNE, INC. 1815 EAST CARNEGIE AVE. Santa Ana, CA 92705 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-09 |
| Decision Date | 1985-10-07 |