The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Edwards E360 Surgical Ablation Device.
| Device ID | K041739 |
| 510k Number | K041739 |
| Device Name: | EDWARDS E360 SURGICAL ABLATION DEVICE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Contact | Elizabeth Moran |
| Correspondent | Elizabeth Moran EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-28 |
| Decision Date | 2004-09-29 |
| Summary: | summary |