The following data is part of a premarket notification filed by Epicor Medical, Inc. with the FDA for Ultracinch Ablation Device, Ultracinch Accessory Pack, Models Uc-8, Uc-9, Uc-10, Uc-11, Uc-12, Uc-13, Uc-14, Uc-acc-1.
| Device ID | K040641 |
| 510k Number | K040641 |
| Device Name: | ULTRACINCH ABLATION DEVICE, ULTRACINCH ACCESSORY PACK, MODELS UC-8, UC-9, UC-10, UC-11, UC-12, UC-13, UC-14, UC-ACC-1 |
| 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 | 2004-03-10 |
| Decision Date | 2004-05-05 |
| Summary: | summary |