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 |