The following data is part of a premarket notification filed by Covidien Llc with the FDA for Emprint Ablation System With Thermosphere Technology.
| Device ID | K200796 |
| 510k Number | K200796 |
| Device Name: | Emprint Ablation System With Thermosphere Technology |
| Classification | System, Ablation, Microwave And Accessories |
| Applicant | Covidien LLC 5920 Longbow Drive Boulder, CO 80301 |
| Contact | Liron Bar Yaakov |
| Correspondent | Liron Bar Yaakov Covidien LLC 5920 Longbow Drive Boulder, CO 80301 |
| Product Code | NEY |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-26 |
| Decision Date | 2020-08-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521813014 | K200796 | 000 |
| 10884521781276 | K200796 | 000 |
| 10884521806443 | K200796 | 000 |