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 |