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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Automatic Carbon-Dioxide For Endoscope
510(k) Number K230474
Device Name EVA5 Insufflator
Applicant
Palliare Ltd.
Galway Business Park, Dangan
Galway,  IE H91 P2DK
Applicant Contact John O'Dea
Correspondent
Palliare Ltd. c/o ProMedic Consulting, LLC
131 Bay Point Dr. NE
St. Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number876.1500
Classification Product Code
FCX  
Date Received02/22/2023
Decision Date 03/24/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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