The following data is part of a premarket notification filed by Medical Technical Gases Inc.. with the FDA for Med-tech Laser Gas Mixture.
| Device ID | K953933 |
| 510k Number | K953933 |
| Device Name: | MED-TECH LASER GAS MIXTURE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | MEDICAL TECHNICAL GASES INC.. 20 HALL ST. Medford, MA 02155 |
| Contact | Ramesh V Kapur |
| Correspondent | Ramesh V Kapur MEDICAL TECHNICAL GASES INC.. 20 HALL ST. Medford, MA 02155 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-18 |
| Decision Date | 1995-09-01 |