The following data is part of a premarket notification filed by Palliare Ltd. with the FDA for Eva15.
| Device ID | K202799 |
| 510k Number | K202799 |
| Device Name: | EVA15 |
| Classification | Insufflator, Laparoscopic |
| Applicant | Palliare Ltd. Galway Business Park, Dangan Galway, IE H91 P2dk |
| Contact | John O'dea |
| Correspondent | Paul Dryden Palliare Ltd. C/o ProMedic Consulting, LLC 131 Bay Point Dr. NE St. Petersburg, FL 33704 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-23 |
| Decision Date | 2020-10-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391536920012 | K202799 | 000 |
| 05391536920029 | K202799 | 000 |
| 05391536920913 | K202799 | 000 |