The following data is part of a premarket notification filed by Norco, Inc. with the FDA for Carbon Dioxide Flowthrough Laser Mixtures.
| Device ID | K904162 |
| 510k Number | K904162 |
| Device Name: | CARBON DIOXIDE FLOWTHROUGH LASER MIXTURES |
| Classification | Powered Laser Surgical Instrument |
| Applicant | NORCO, INC. 1121 WEST AMITY Boise, ID 83705 |
| Contact | Lyle Feely |
| Correspondent | Lyle Feely NORCO, INC. 1121 WEST AMITY Boise, ID 83705 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-11 |
| Decision Date | 1990-10-19 |