The following data is part of a premarket notification filed by Palliare Ltd. with the FDA for End 200 Endoscopic Tubeset.
| Device ID | K202922 |
| 510k Number | K202922 |
| Device Name: | END 200 Endoscopic Tubeset |
| Classification | Insufflator, Automatic Carbon-dioxide For Endoscope |
| 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 | FCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-29 |
| Decision Date | 2021-07-08 |