The following data is part of a premarket notification filed by Sorenson Laboratories, Inc. with the FDA for Safe Air Vari-spot Handpiece Telescope And Adaptor.
| Device ID | K931356 |
| 510k Number | K931356 |
| Device Name: | SAFE AIR VARI-SPOT HANDPIECE TELESCOPE AND ADAPTOR |
| Classification | Lens, Surgical, Laser, Accesssory, Ophthalmic Laser |
| Applicant | SORENSON LABORATORIES, INC. 2495 SOUTH WEST TEMPLE Salt Lake City, UT 84115 |
| Contact | Linda Rittenhouse |
| Correspondent | Linda Rittenhouse SORENSON LABORATORIES, INC. 2495 SOUTH WEST TEMPLE Salt Lake City, UT 84115 |
| Product Code | LQJ |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-17 |
| Decision Date | 1993-09-07 |