The following data is part of a premarket notification filed by Sorex Medical with the FDA for Sorex Safe-air.
| Device ID | K911150 |
| 510k Number | K911150 |
| Device Name: | SOREX SAFE-AIR |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SOREX MEDICAL 5725 WEST HAROLD GATTY DR. Salt Lake City, UT 84116 |
| Contact | Joseph T Sorenson |
| Correspondent | Joseph T Sorenson SOREX MEDICAL 5725 WEST HAROLD GATTY DR. Salt Lake City, UT 84116 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-15 |
| Decision Date | 1991-06-28 |