The following data is part of a premarket notification filed by Spectra Gases, Inc. with the FDA for Gas Mixtures As Device Components.
| Device ID | K896412 |
| 510k Number | K896412 |
| Device Name: | GAS MIXTURES AS DEVICE COMPONENTS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SPECTRA GASES, INC. 320 MOUNT PLEASANT AVE. Newark, NJ 07104 |
| Contact | James E Gerety |
| Correspondent | James E Gerety SPECTRA GASES, INC. 320 MOUNT PLEASANT AVE. Newark, NJ 07104 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-08 |
| Decision Date | 1990-02-01 |