The following data is part of a premarket notification filed by Microsulis Americas, Inc. with the FDA for Microsulis Tissue Ablation System.
| Device ID | K052919 |
| 510k Number | K052919 |
| Device Name: | MICROSULIS TISSUE ABLATION SYSTEM |
| Classification | System, Ablation, Microwave And Accessories |
| Applicant | MICROSULIS AMERICAS, INC. 275 WYMAN STREET,SUITE 12 Waltham, MA 02451 |
| Contact | Timothy Y Cowart |
| Correspondent | Timothy Y Cowart MICROSULIS AMERICAS, INC. 275 WYMAN STREET,SUITE 12 Waltham, MA 02451 |
| Product Code | NEY |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-17 |
| Decision Date | 2006-01-13 |
| Summary: | summary |