The following data is part of a premarket notification filed by Laser Industries Ltd. with the FDA for Sharplan Smoke Evacuation Unit, Model 100.
| Device ID | K894765 |
| 510k Number | K894765 |
| Device Name: | SHARPLAN SMOKE EVACUATION UNIT, MODEL 100 |
| Classification | Apparatus, Exhaust, Surgical |
| Applicant | LASER INDUSTRIES LTD. 1 PEARL COURT Allendale, NJ 07401 |
| Contact | Mark Plotts |
| Correspondent | Mark Plotts LASER INDUSTRIES LTD. 1 PEARL COURT Allendale, NJ 07401 |
| Product Code | FYD |
| CFR Regulation Number | 878.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-26 |
| Decision Date | 1989-09-28 |