The following data is part of a premarket notification filed by Mitek Products with the FDA for Vapr 2.3mm Wedge Electrode For Use With Vapr System.
| Device ID | K000936 |
| 510k Number | K000936 |
| Device Name: | VAPR 2.3MM WEDGE ELECTRODE FOR USE WITH VAPR SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MITEK PRODUCTS 60 GLACIER DR. Westwood, MA 02090 |
| Contact | Mary P Legraw |
| Correspondent | Mary P Legraw MITEK PRODUCTS 60 GLACIER DR. Westwood, MA 02090 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-23 |
| Decision Date | 2000-04-19 |