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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
510(k) Number K191505
Device Name Rezum System
Applicant
Nxthera (A Boston Scientific Company)
100 Boston Scientific Way
Marborough,  MA  01752
Applicant Contact Justin Kapitan
Correspondent
Nxthera (A Boston Scientific Company)
100 Boston Scientific Way
Marborough,  MA  01752
Correspondent Contact Justin Kapitan
Regulation Number876.4300
Classification Product Code
KNS  
Date Received06/06/2019
Decision Date 08/02/2019
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
Predetermined Change
Control Plan Authorized		 No
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