The following data is part of a premarket notification filed by Laser Technologies Group, Inc. with the FDA for Plume-away Smoke Evacuation System.
| Device ID | K894038 |
| 510k Number | K894038 |
| Device Name: | PLUME-AWAY SMOKE EVACUATION SYSTEM |
| Classification | Apparatus, Exhaust, Surgical |
| Applicant | LASER TECHNOLOGIES GROUP, INC. 6550 YORK AVENUE SOUTH SUITE 412 Edina, MN 55435 |
| Contact | Donald Hewitt |
| Correspondent | Donald Hewitt LASER TECHNOLOGIES GROUP, INC. 6550 YORK AVENUE SOUTH SUITE 412 Edina, MN 55435 |
| Product Code | FYD |
| CFR Regulation Number | 878.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-06 |
| Decision Date | 1989-09-28 |