The following data is part of a premarket notification filed by Union Carbide Corp. with the FDA for Laser Gas Mixtures.
| Device ID | K820535 |
| 510k Number | K820535 |
| Device Name: | LASER GAS MIXTURES |
| Classification | Laser, Ent Microsurgical Carbon-dioxide |
| Applicant | UNION CARBIDE CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EWG |
| CFR Regulation Number | 874.4500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-03-02 |
| Decision Date | 1982-03-31 |