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 |