The following data is part of a premarket notification filed by Epicor Medical, Inc. with the FDA for Epicor Medical Ablation System.
| Device ID | K022894 |
| 510k Number | K022894 |
| Device Name: | EPICOR MEDICAL ABLATION SYSTEM |
| Classification | System, Ablation, Ultrasound And Accessories |
| Applicant | EPICOR MEDICAL, INC. 240 SANTA ANA COURT Sunnyvale, CA 94085 |
| Contact | Kathi Guerrant |
| Correspondent | Kathi Guerrant EPICOR MEDICAL, INC. 240 SANTA ANA COURT Sunnyvale, CA 94085 |
| Product Code | NTB |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-03 |
| Decision Date | 2004-02-26 |
| Summary: | summary |