The following data is part of a premarket notification filed by Atricure, Inc. with the FDA for Atricure Dissector.
| Device ID | K041681 |
| 510k Number | K041681 |
| Device Name: | ATRICURE DISSECTOR |
| Classification | Lamp, Surgical |
| Applicant | ATRICURE, INC. 6033 SCHUMACHER PARK DR. West Chester, OH 45069 |
| Contact | Mark Job |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | FTD |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-06-21 |
| Decision Date | 2004-07-01 |
| Summary: | summary |