The following data is part of a premarket notification filed by Rita Medical Systems with the FDA for Rita Model 2500 Electrosurgical Rf Generator.
Device ID | K003676 |
510k Number | K003676 |
Device Name: | RITA MODEL 2500 ELECTROSURGICAL RF GENERATOR |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | RITA MEDICAL SYSTEMS 967 NORTH SHORELINE BLVD. Mountain View, CA 94043 |
Contact | Erin Mazzone |
Correspondent | Erin Mazzone RITA MEDICAL SYSTEMS 967 NORTH SHORELINE BLVD. Mountain View, CA 94043 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-11-29 |
Decision Date | 2001-04-09 |