The following data is part of a premarket notification filed by Airgas Management, Inc. with the FDA for Laser Gas Mixture.
| Device ID | K952301 |
| 510k Number | K952301 |
| Device Name: | LASER GAS MIXTURE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | AIRGAS MANAGEMENT, INC. 1515 ABBY ALDRICH Kathy, TX 77449 -3006 |
| Contact | Ralph A Diaz |
| Correspondent | Ralph A Diaz AIRGAS MANAGEMENT, INC. 1515 ABBY ALDRICH Kathy, TX 77449 -3006 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-16 |
| Decision Date | 1995-06-01 |