EVA 15 Insufflator

Insufflator, Laparoscopic

Palliare Ltd.

The following data is part of a premarket notification filed by Palliare Ltd. with the FDA for Eva 15 Insufflator.

Pre-market Notification Details

Device IDK193520
510k NumberK193520
Device Name:EVA 15 Insufflator
ClassificationInsufflator, Laparoscopic
Applicant Palliare Ltd. Galway Business Park, Dangan Galway,  IE H91 92dk
ContactJohn O'dea
CorrespondentPaul Dryden
Palliare Ltd C/o ProMedic LLC 131 Bay Point Dr. NE St. Petersburg,  FL  33704
Product CodeHIF  
CFR Regulation Number884.1730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-19
Decision Date2020-07-23

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