The following data is part of a premarket notification filed by Conmed Corp. with the FDA for Conmed System 2000 Electrosurgical Generator, Ref: 60-8002; Conmed Esu Cart, Ref: 60-6120.
| Device ID | K020135 |
| 510k Number | K020135 |
| Device Name: | CONMED SYSTEM 2000 ELECTROSURGICAL GENERATOR, REF: 60-8002; CONMED ESU CART, REF: 60-6120 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | CONMED CORP. 14603 E. FREMONT AVE. Centennial, CO 80112 |
| Contact | Charles M Hart |
| Correspondent | Charles M Hart CONMED CORP. 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 | 2002-01-15 |
| Decision Date | 2002-04-12 |