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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, retention type, balloon
510(k) Number K173533
Device Name Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter
Applicant
Poiesis Medical, LLC
1095 Jupiter Park Drive
Suite 10
Jupiter,  FL  33458
Applicant Contact Greg Wiita
Correspondent
Powers Regulatory Consulting
2451 Cumberland Parkway SE
Suite 3740
Atlanta,  GA  30339
Correspondent Contact Grace Powers
Regulation Number876.5130
Classification Product Code
EZL  
Date Received11/15/2017
Decision Date 03/29/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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