The following data is part of a premarket notification filed by Liquid Carbonic Industrial Gases with the FDA for Laser Gas Mixture.
| Device ID | K951045 |
| 510k Number | K951045 |
| Device Name: | LASER GAS MIXTURE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LIQUID CARBONIC INDUSTRIAL GASES 810 JORIE BLVD. Oak Brook, IL 60521 -2216 |
| Contact | Mark D Lange |
| Correspondent | Mark D Lange LIQUID CARBONIC INDUSTRIAL GASES 810 JORIE BLVD. Oak Brook, IL 60521 -2216 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-06 |
| Decision Date | 1995-03-31 |