The following data is part of a premarket notification filed by Curon Medical, Inc. with the FDA for Curon Control Module Electrosurgical Generator And Accessories, Model S500-st.
| Device ID | K002898 |
| 510k Number | K002898 |
| Device Name: | CURON CONTROL MODULE ELECTROSURGICAL GENERATOR AND ACCESSORIES, MODEL S500-ST |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | CURON MEDICAL, INC. 735 PALOMAR ST. Sunnyvale, CA 94086 |
| Contact | Thomas C Wehman |
| Correspondent | Thomas C Wehman CURON MEDICAL, INC. 735 PALOMAR ST. Sunnyvale, CA 94086 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-18 |
| Decision Date | 2000-10-17 |