The following data is part of a premarket notification filed by Acetylene Gas Co. with the FDA for Medical Laser Mixture.
| Device ID | K935310 |
| 510k Number | K935310 |
| Device Name: | MEDICAL LASER MIXTURE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ACETYLENE GAS CO. 3500 BERNARD St. Louis, MO 63103 |
| Contact | Kris Luther |
| Correspondent | Kris Luther ACETYLENE GAS CO. 3500 BERNARD St. Louis, MO 63103 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-02 |
| Decision Date | 1993-12-23 |