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 |