The following data is part of a premarket notification filed by Mitek Products with the FDA for Varpr 3.5mm 90 Suction Electrode For Use With Vapr System.
| Device ID | K002422 |
| 510k Number | K002422 |
| Device Name: | VARPR 3.5MM 90 SUCTION ELECTRODE FOR USE WITH VAPR SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MITEK PRODUCTS 249 VANDERBILT AVE. Norwood, MA 02062 |
| Contact | Mary P Legraw |
| Correspondent | Mary P Legraw MITEK PRODUCTS 249 VANDERBILT AVE. Norwood, MA 02062 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-08 |
| Decision Date | 2000-08-31 |