The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Arthroscopic Energy System.
Device ID | K140578 |
510k Number | K140578 |
Device Name: | ARTHROSCOPIC ENERGY SYSTEM |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | CONMED CORPORATION 525 FRENCH RD. Utica, NY 13502 |
Contact | Dionne Sanders |
Correspondent | Dionne Sanders CONMED CORPORATION 525 FRENCH RD. Utica, NY 13502 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-03-06 |
Decision Date | 2014-07-23 |
Summary: | summary |