The following data is part of a premarket notification filed by Lmi Lightwave Medical Industries Ltd. with the FDA for Lumitrol Controller, Lumitrol Hand-controlled Electrosurgical Pencil With Blade Electrode.
| Device ID | K953992 |
| 510k Number | K953992 |
| Device Name: | LUMITROL CONTROLLER, LUMITROL HAND-CONTROLLED ELECTROSURGICAL PENCIL WITH BLADE ELECTRODE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | LMI LIGHTWAVE MEDICAL INDUSTRIES LTD. 2660 OAK ST. Vancouver, B.c., CA V6h 3z6 |
| Contact | Martin Poulin |
| Correspondent | Martin Poulin LMI LIGHTWAVE MEDICAL INDUSTRIES LTD. 2660 OAK ST. Vancouver, B.c., CA V6h 3z6 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-24 |
| Decision Date | 1995-10-23 |