The following data is part of a premarket notification filed by Coherent Medical Division with the FDA for Accessories For Sys. 400 Co2 Surg. Laser.
| Device ID | K791895 |
| 510k Number | K791895 |
| Device Name: | ACCESSORIES FOR SYS. 400 CO2 SURG. LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | COHERENT MEDICAL DIVISION 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-09-25 |
| Decision Date | 1979-12-20 |