The following data is part of a premarket notification filed by Mitek Products with the FDA for Vapr 2.3mm End Effect Electrode For Use With Vapr System.
| Device ID | K992406 |
| 510k Number | K992406 |
| Device Name: | VAPR 2.3MM END EFFECT ELECTRODE FOR USE WITH VAPR SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MITEK PRODUCTS 60 GLACIER DR. Westwood, MA 02090 |
| Contact | Paula E Bulger |
| Correspondent | Paula E Bulger 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 | 1999-07-20 |
| Decision Date | 1999-08-06 |
| Summary: | summary |