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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Laparoscopic
510(k) Number K193520
Device Name EVA 15 Insufflator
Applicant
Palliare , Ltd.
Galway Business Park, Dangan
Galway,  IE H91 92DK
Applicant Contact John O'Dea
Correspondent
Palliare, Ltd. C/O Promedic, LLC
131 Bay Pt. Dr. NE
St. Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number884.1730
Classification Product Code
HIF  
Date Received12/19/2019
Decision Date 07/23/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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