Insufflator, Laparoscopic

Palliare Ltd.

The following data is part of a premarket notification filed by Palliare Ltd. with the FDA for Eva15.

Pre-market Notification Details

Device IDK202799
510k NumberK202799
Device Name:EVA15
ClassificationInsufflator, Laparoscopic
Applicant Palliare Ltd. Galway Business Park, Dangan Galway,  IE H91 P2dk
ContactJohn O'dea
CorrespondentPaul Dryden
Palliare Ltd. C/o ProMedic Consulting, LLC 131 Bay Point Dr. NE St. Petersburg,  FL  33704
Product CodeHIF  
CFR Regulation Number884.1730 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-23
Decision Date2020-10-21

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.