The following data is part of a premarket notification filed by Tivamed, Inc. with the FDA for Tivamed Cooled Rf System, Model 78001.
| Device ID | K082962 |
| 510k Number | K082962 |
| Device Name: | TIVAMED COOLED RF SYSTEM, MODEL 78001 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | TIVAMED, INC. 4410 EL CAMINO REAL, SUITE 204 Los Altos, CA 94022 |
| Contact | Shelley Trimm |
| Correspondent | Shelley Trimm TIVAMED, INC. 4410 EL CAMINO REAL, SUITE 204 Los Altos, CA 94022 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-03 |
| Decision Date | 2008-12-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850794007194 | K082962 | 000 |
| 10850794007016 | K082962 | 000 |
| 10850794007023 | K082962 | 000 |
| 10850794007054 | K082962 | 000 |
| 10850794007078 | K082962 | 000 |
| 00850794007088 | K082962 | 000 |
| 00850794007101 | K082962 | 000 |
| 00850794007118 | K082962 | 000 |
| 00850794007132 | K082962 | 000 |
| 00850794007163 | K082962 | 000 |
| 00850794007170 | K082962 | 000 |
| 00850794007187 | K082962 | 000 |
| 10850794007009 | K082962 | 000 |