The following data is part of a premarket notification filed by Mitek Products with the FDA for Vapr Tc Electrode For Use With Vapr Ii Electrosurgical System.
Device ID | K002402 |
510k Number | K002402 |
Device Name: | VAPR TC ELECTRODE FOR USE WITH VAPR II ELECTROSURGICAL SYSTEM |
Classification | Arthroscope |
Applicant | MITEK PRODUCTS 249 VANDERBILT AVE. Norwood, MA 02062 |
Contact | Mary P Legaw |
Correspondent | Mary P Legaw MITEK PRODUCTS 249 VANDERBILT AVE. Norwood, MA 02062 |
Product Code | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-08-07 |
Decision Date | 2000-08-31 |