The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Conmed System Model 2450 Electrosurgical Generator.
Device ID | K052009 |
510k Number | K052009 |
Device Name: | CONMED SYSTEM MODEL 2450 ELECTROSURGICAL GENERATOR |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | CONMED CORPORATION 14603 E. FREMONT AVE. Centennial, CO 80112 |
Contact | Pamela Vetter |
Correspondent | Pamela Vetter CONMED CORPORATION 14603 E. FREMONT AVE. Centennial, CO 80112 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-07-25 |
Decision Date | 2005-09-28 |
Summary: | summary |