The following data is part of a premarket notification filed by Sorenson Laboratories, Inc. with the FDA for Plumemaster Smoke Evacuation System.
| Device ID | K930434 |
| 510k Number | K930434 |
| Device Name: | PLUMEMASTER SMOKE EVACUATION SYSTEM |
| Classification | Apparatus, Exhaust, Surgical |
| 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 | FYD |
| CFR Regulation Number | 878.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-26 |
| Decision Date | 1993-11-16 |